The FDA has approved Eli Lilly’s obesity treatment, Zepbound, for the management of moderate to severe obstructive sleep apnea in people with obesity. This marks the first time a medication has been approved to treat this condition.

<h2>The link between obesity and sleep apnea</h2>

Obstructive sleep apnea is a serious condition that disrupts breathing and sleep and is commonly associated with obesity. Many individuals experience improvements in their sleep apnea symptoms as they lose weight, suggesting that weight loss may play a key role in managing the disorder. The expanded approval of Zepbound, which aids in weight loss, is expected to help improve sleep apnea in affected individuals.

Currently, obstructive sleep apnea is only treated with a positive airway pressure (PAP) device, as there is no approved medication for the condition. Zepbound’s approval for use in sleep apnea means that insurance providers, including Medicare, are likely to cover its cost for individuals with both obesity and sleep apnea. This is a significant change, as many insurance plans do not reimburse treatments for obesity alone.

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<h2>Targeting obesity-related sleep apnea</h2>

The new approval applies to adults with moderate to severe obstructive sleep apnea who also have obesity, a group estimated to number between 15 to 20 million people in the US.

Common signs of sleep apnea include loud snoring, breathing pauses during sleep, daytime drowsiness, forgetfulness and morning headaches. These symptoms can result in serious health problems if left untreated.

Also read |&nbsp;<a href="https://www.wionews.com/science/aging-a-thing-of-the-past-new-study-finds-70-is-the-new-60-785451">Ageing a thing of the past? New study finds 70 is the new 60 because...</a>

<h2>How Zepbound works in sleep apnea treatment</h2>

While the exact mechanism by which Zepbound improves sleep apnea symptoms remains unclear, it is believed that the weight loss associated with the drug may be the key factor.

Zepbound contains tirzepatide, which may also have other effects on the body. In clinical trials, participants using Zepbound lost an average of 20 per cent of their body weight, which likely contributed to improvements in their sleep apnea symptoms.

(With inputs from agencies)

The FDA has approved Eli Lilly’s obesity treatment, Zepbound, for the management of moderate to severe obstructive sleep apnea in people with obesity. This marks the first time a medication has been approved to treat this condition.

The FDA has approved Eli Lilly’s obesity treatment, Zepbound, for the management of moderate to severe obstructive sleep apnea in people with obesity. This marks the first time a medication has been approved to treat this condition. The link between obesity and sleep apnea Obstructive sleep apnea is a serious condition that disrupts breathing and sleep and is commonly associated with obesity. Many individuals experience improvements in their sleep apnea symptoms as they lose weight, suggesting that weight loss may play a key role in managing the disorder. The expanded approval of Zepbound, which aids in weight loss, is expected to help improve sleep apnea in affected individuals. Currently, obstructive sleep apnea is only treated with a positive airway pressure (PAP) device, as there is no approved medication for the condition. Zepbound’s approval for use in sleep apnea means that insurance providers, including Medicare, are likely to cover its cost for individuals with both obesity and sleep apnea. This is a significant change, as many insurance plans do not reimburse treatments for obesity alone. Also read | Mystery illness 'Dinga Dinga' leaves 300 in Uganda shaking uncontrollably Targeting obesity-related sleep apnea The new approval applies to adults with moderate to severe obstructive sleep apnea who also have obesity, a group estimated to number between 15 to 20 million people in the US. Common signs of sleep apnea include loud snoring, breathing pauses during sleep, daytime drowsiness, forgetfulness and morning headaches. These symptoms can result in serious health problems if left untreated. Also read | Ageing a thing of the past? New study finds 70 is the new 60 because... How Zepbound works in sleep apnea treatment While the exact mechanism by which Zepbound improves sleep apnea symptoms remains unclear, it is believed that the weight loss associated with the drug may be the key factor. Zepbound contains tirzepatide, which may also have other effects on the body. In clinical trials, participants using Zepbound lost an average of 20 per cent of their body weight, which likely contributed to improvements in their sleep apnea symptoms. (With inputs from agencies)

FDA expands weight loss drug Zepbound approval to treat sleep apnea

Washington DC, United States
The FDA has approved Eli Lilly’s obesity treatment, Zepbound, for the management of moderate to severe obstructive sleep apnea in people with obesity. This marks the first time a medication has been approved to treat this condition.
<h2>The link between obesity and sleep apnea</h2>
Obstructive sleep apnea is a serious condition that disrupts breathing and sleep and is commonly associated with obesity. Many individuals experience improvements in their sleep apnea symptoms as they lose weight, suggesting that weight loss may play a key role in managing the disorder. The expanded approval of Zepbound, which aids in weight loss, is expected to help improve sleep apnea in affected individuals.
Currently, obstructive sleep apnea is only treated with a positive airway pressure (PAP) device, as there is no approved medication for the condition. Zepbound’s approval for use in sleep apnea means that insurance providers, including Medicare, are likely to cover its cost for individuals with both obesity and sleep apnea. This is a significant change, as many insurance plans do not reimburse treatments for obesity alone.
Also read | <a href="https://www.wionews.com/world/mystery-illness-dinga-dinga-leaves-300-in-uganda-shaking-uncontrollably-785363">Mystery illness 'Dinga Dinga' leaves 300 in Uganda shaking uncontrollably</a>
<h2>Targeting obesity-related sleep apnea</h2>
The new approval applies to adults with moderate to severe obstructive sleep apnea who also have obesity, a group estimated to number between 15 to 20 million people in the US.
Common signs of sleep apnea include loud snoring, breathing pauses during sleep, daytime drowsiness, forgetfulness and morning headaches. These symptoms can result in serious health problems if left untreated.
Also read | <a href="https://www.wionews.com/science/aging-a-thing-of-the-past-new-study-finds-70-is-the-new-60-785451">Ageing a thing of the past? New study finds 70 is the new 60 because...</a>
<h2>How Zepbound works in sleep apnea treatment</h2>
While the exact mechanism by which Zepbound improves sleep apnea symptoms remains unclear, it is believed that the weight loss associated with the drug may be the key factor.
Zepbound contains tirzepatide, which may also have other effects on the body. In clinical trials, participants using Zepbound lost an average of 20 per cent of their body weight, which likely contributed to improvements in their sleep apnea symptoms.
(With inputs from agencies)

Obstructive sleep apnea is a serious condition that disrupts breathing and sleep and is commonly associated with obesity. 



Washington DC, United States The FDA has approved Eli Lilly’s obesity treatment, Zepbound, for the management of moderate to severe obstructive sleep apnea in people with obesity. This marks the first time a medication has been approved to treat this condition. The link between obesity and sleep apnea Obstructive sleep apnea is a serious condition that disrupts breathing and sleep and is commonly associated with obesity. Many individuals experience improvements in their sleep apnea symptoms as they lose weight, suggesting that weight loss may play a key role in managing the disorder. The expanded approval of Zepbound, which aids in weight loss, is expected to help improve sleep apnea in affected individuals. Currently, obstructive sleep apnea is only treated with a positive airway pressure (PAP) device, as there is no approved medication for the condition. Zepbound’s approval for use in sleep apnea means that insurance providers, including Medicare, are likely to cover its cost for individuals with both obesity and sleep apnea. This is a significant change, as many insurance plans do not reimburse treatments for obesity alone. Also read | Mystery illness 'Dinga Dinga' leaves 300 in Uganda shaking uncontrollably Targeting obesity-related sleep apnea The new approval applies to adults with moderate to severe obstructive sleep apnea who also have obesity, a group estimated to number between 15 to 20 million people in the US. Common signs of sleep apnea include loud snoring, breathing pauses during sleep, daytime drowsiness, forgetfulness and morning headaches. These symptoms can result in serious health problems if left untreated. Also read | Ageing a thing of the past? New study finds 70 is the new 60 because... How Zepbound works in sleep apnea treatment While the exact mechanism by which Zepbound improves sleep apnea symptoms remains unclear, it is believed that the weight loss associated with the drug may be the key factor. Zepbound contains tirzepatide, which may also have other effects on the body. In clinical trials, participants using Zepbound lost an average of 20 per cent of their body weight, which likely contributed to improvements in their sleep apnea symptoms. (With inputs from agencies)

A panel of advisors of the Food and Drug Administration on Tuesday (Oct 31) held a day-long meeting grappling with potential risks posed by a novel therapy for sickle cell disease, a rare blood disorder that affects a significant population globally.

If green-lit by the FDA, it could be a groundbreaking solution for many individuals battling severe forms of the rare blood disorder.

<h2>A novel therapy</h2>

The therapy called exa-cel, which has been developed by Vertex Pharmaceuticals, harnesses CRISPR gene editing technology to potentially cure sickle cell disease.&nbsp;

As per a press release by Vertes, the FDA is expected to decide on exa-cel by December 8.

Documents released before Tuesday's meeting show that the FDA concurred with the company's portrayal of the therapy's trials, acknowledging the "strongly positive results".&nbsp;

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Speaking at the meeting, Dr Nicole Verdun, head of the FDA's Office of Therapeutics Products, said: "It is an exciting time in cell and gene therapy that we are beginning to address some of this unmet need in a variety of diseases. Exa-cel has been studied for treatment of sickle cell disease with severe vaso-occlusive crises and has shown efficacy and safety."&nbsp;

Throughout the discussion, the FDA, as per CBS News, emphasised the importance of minimising unintended gene alterations, raising concerns about potential off-target editing and the associated risks.&nbsp;

"If the gene happens to play an essential role in cell function, then such unintended edits can be deleterious. These edits can also increase the risk of cancer," said the FDA's Komudi Singh, a bioinformatics reviewer for the agency.

However, experts underscored the absence of concrete evidence indicating adverse effects from unintended changes.

As per Dr Daniel Bauer, a researcher at Boston Children's Hospital, "Theoretically, could it? Yes. Is there evidence to suggest that it does? I would say no. But this hasn't really been done very much. We need to be humble and open to learning from these brave patients who are participating."

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Largely supporting the treatment, committee members advocated for continued vigilance and long-term monitoring to fully grasp the treatment's impact.

<h2>Sickle cell disease</h2>

In the USA alone, around 100,000 people, predominantly from Black communities, are affected by sickle cell disease, according to estimates by the CDC.

Currently, blood and bone marrow transplants are the only available cures for this disease.&nbsp;

These too, are accessible to only a small fraction of patients as they depend on finding close genetic matches to them.

Sickle cell disease causes a range of debilitating complications, including agonising vaso-occlusive crises — where blood flow is blocked in the body — described as "bone-crushing pain" by one patient.

(With inputs from agencies)

A panel of advisors of the Food and Drug Administration on Tuesday (Oct 31) held a day-long meeting grappling with potential risks posed by a novel therapy for sickle cell disease, a rare blood disorder that affects a significant population globally.

A panel of advisors of the Food and Drug Administration on Tuesday (Oct 31) held a day-long meeting grappling with potential risks posed by a novel therapy for sickle cell disease, a rare blood disorder that affects a significant population globally. If green-lit by the FDA, it could be a groundbreaking solution for many individuals battling severe forms of the rare blood disorder. A novel therapy The therapy called exa-cel, which has been developed by Vertex Pharmaceuticals, harnesses CRISPR gene editing technology to potentially cure sickle cell disease. As per a press release by Vertes, the FDA is expected to decide on exa-cel by December 8. Documents released before Tuesday's meeting show that the FDA concurred with the company's portrayal of the therapy's trials, acknowledging the "strongly positive results". Also read | Air pollution ups risk of Parkinson's disease by 56%: Study Speaking at the meeting, Dr Nicole Verdun, head of the FDA's Office of Therapeutics Products, said: "It is an exciting time in cell and gene therapy that we are beginning to address some of this unmet need in a variety of diseases. Exa-cel has been studied for treatment of sickle cell disease with severe vaso-occlusive crises and has shown efficacy and safety." Throughout the discussion, the FDA, as per CBS News, emphasised the importance of minimising unintended gene alterations, raising concerns about potential off-target editing and the associated risks. "If the gene happens to play an essential role in cell function, then such unintended edits can be deleterious. These edits can also increase the risk of cancer," said the FDA's Komudi Singh, a bioinformatics reviewer for the agency. However, experts underscored the absence of concrete evidence indicating adverse effects from unintended changes. As per Dr Daniel Bauer, a researcher at Boston Children's Hospital, "Theoretically, could it? Yes. Is there evidence to suggest that it does? I would say no. But this hasn't really been done very much. We need to be humble and open to learning from these brave patients who are participating." Also read | ‘His own body attacked it,’ Second person to get pig heart transplant dies Largely supporting the treatment, committee members advocated for continued vigilance and long-term monitoring to fully grasp the treatment's impact. Sickle cell disease In the USA alone, around 100,000 people, predominantly from Black communities, are affected by sickle cell disease, according to estimates by the CDC. Currently, blood and bone marrow transplants are the only available cures for this disease. These too, are accessible to only a small fraction of patients as they depend on finding close genetic matches to them. Sickle cell disease causes a range of debilitating complications, including agonising vaso-occlusive crises — where blood flow is blocked in the body — described as "bone-crushing pain" by one patient. (With inputs from agencies)

FDA weighs risks and benefits of CRISPR therapy for sickle cell disease

The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer's therapy for the treatment of a challenging form of blood cancer, the company announced on Monday.

This approval, as per Reuters, hinges on compelling data from a mid-stage study, which revealed that 58 per cent of patients treated with Pfizer's therapy exhibited either no cancer presence or a significant reduction in cancer cells.

<h2>Elrexfio</h2>

This groundbreaking decision permits the use of Pfizer's therapy 'Elrexfio', in patients dealing with multiple myeloma, a type of blood cancer that is often resistant to conventional treatment and reoccurs even after a patient undergoes four or more rounds of certain classes of treatments, reports Reuters.

The drug, which is administered subcutaneously, or under the skin, is also known as elranatamab, and belongs to the class of bi-specific antibodies — these boost the immune system's ability to target and eliminate cancerous cells by bringing together immune cells with cancer cells.

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For patients in America, the therapy will be sold at $7,556 for the 44 mg vial and $13,051 for the 76 mg vial, according to Pfizer.&nbsp;

The therapy's initial list price, as per the company, is expected to be approximately $41,500 per month. However, Pfizer anticipates that the monthly cost will decrease to around $26,000 as patients transition to bi-weekly dosing.

<h2>When will it be available?</h2>

Mid-stage trial results indicate that Elrexfio has an average treatment duration of eight months. As per Pfizer, it should be available to patients in the weeks following the FDA approval.

<h2>Blood cancer</h2>

Multiple myeloma is a prevalent type of blood cancer that originates in the bone marrow. It can metastasise throughout the body.&nbsp;

Patients often experience disease recurrence after discontinuing treatment. Elrexfio may help address this unmet medical need.

Similar antibody therapies in the market include Roche's Columvi, Abbvie's Epkinly, and Johnson &amp; Johnson's recently approved Talvey.

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A distinctive aspect of Elrexfio is its potential for "off-the-shelf" usage. Healthcare providers in hospitals and clinics can administer the therapy on an ongoing basis, enhancing accessibility for patients, said the company.

It is noteworthy that the therapy's approval comes with a boxed warning related to neurologic toxicity and cytokine release syndrome, a condition marked by an intensified immune system response.

(With inputs from agencies)

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The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer's therapy for the treatment of a challenging form of blood cancer, the company announced on Monday.

The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer's therapy for the treatment of a challenging form of blood cancer, the company announced on Monday. This approval, as per Reuters, hinges on compelling data from a mid-stage study, which revealed that 58 per cent of patients treated with Pfizer's therapy exhibited either no cancer presence or a significant reduction in cancer cells. Elrexfio This groundbreaking decision permits the use of Pfizer's therapy 'Elrexfio', in patients dealing with multiple myeloma, a type of blood cancer that is often resistant to conventional treatment and reoccurs even after a patient undergoes four or more rounds of certain classes of treatments, reports Reuters. The drug, which is administered subcutaneously, or under the skin, is also known as elranatamab, and belongs to the class of bi-specific antibodies — these boost the immune system's ability to target and eliminate cancerous cells by bringing together immune cells with cancer cells. Also read | In a worrisome first, scientists detect microplastics in human hearts: Study For patients in America, the therapy will be sold at $7,556 for the 44 mg vial and $13,051 for the 76 mg vial, according to Pfizer. The therapy's initial list price, as per the company, is expected to be approximately $41,500 per month. However, Pfizer anticipates that the monthly cost will decrease to around $26,000 as patients transition to bi-weekly dosing. When will it be available? Mid-stage trial results indicate that Elrexfio has an average treatment duration of eight months. As per Pfizer, it should be available to patients in the weeks following the FDA approval. Blood cancer Multiple myeloma is a prevalent type of blood cancer that originates in the bone marrow. It can metastasise throughout the body. Patients often experience disease recurrence after discontinuing treatment. Elrexfio may help address this unmet medical need. Similar antibody therapies in the market include Roche's Columvi, Abbvie's Epkinly, and Johnson & Johnson's recently approved Talvey. Also read | Scientists unearth Europe’s oldest lakeside stilt village behind a fortress of defensive spikes A distinctive aspect of Elrexfio is its potential for "off-the-shelf" usage. Healthcare providers in hospitals and clinics can administer the therapy on an ongoing basis, enhancing accessibility for patients, said the company. It is noteworthy that the therapy's approval comes with a boxed warning related to neurologic toxicity and cytokine release syndrome, a condition marked by an intensified immune system response. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Pfizer therapy for hard-to-treat blood cancer granted FDA accelerated approval 

The United States Food and Drug Administration (FDA), on Friday (July 28) approved the sale of a second opioid overdose reversal drug called RiVive, said the US government agency, in a statement. It was also the first version of over-the-counter naloxone from a nonprofit company which could lead to cheap and even free doses for those in need.

<h2>Approval of RiVive</h2>

The approval of the prescription-free sale of the second opioid overdose reversal drug, RiVive, will provide patients with another over-the-counter option for emergency treatment of known or suspected opioid overdose.&nbsp;

The US Centers for Disease Control and Prevention (CDC) recommends quickly administering Narcan – the only over-the-counter FDA-approved option until now – which consists of an active drug called naloxone, a life-saving medication and nasal spray used to counter the overdose effects.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/us-one-person-was-killed-every-10-hours-due-to-drug-related-overdose-this-year-in-san-francisco-587112">Every 10 hours, one person died due to drug-related overdose, in San Francisco this year: Report</a>

Narcan, which was approved in March is available in all 50 states and can be procured without a prescription in most states.

Similarly, RiVive, which is also a nasal spray version of the drug naloxone, rapidly reverses or blocks the effects of opioids – especially when administered within minutes of the first signs of an overdose – restoring normal respiration.&nbsp;

“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” said FDA Commissioner Robert&nbsp;Califf, in a statement.&nbsp;

He added, “The agency has long prioritised access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”&nbsp;

<h2>When will it be available?</h2>

The RiVive’s manufacturer Harm Reduction Therapeutics, a nonprofit pharmaceutical company, said that the opioid overdose reversal drug might be available early next year, primarily to harm-reduction organisations and state governments, reported Reuters. The organisation will also make at least 200,000 doses available for free.

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“If we are able to have partners step forward and help fund our work, we can further lower the cost of RiVive, or increase the amount that we give away for free,” said co-founder and CEO Michael Hufford, as quoted by the news agency.&nbsp;

<h2>Drug overdose in US</h2>

RiVive is the second over-the-counter naloxone product approved by the FDA this year. According to the US government agency, more than 105,000 reported fatal overdoses occurred in the 12-month period ending in February 2023. These deaths have predominantly been attributed to synthetic opioids like <a href="https://www.wionews.com/world/explained-fentanyl-seized-in-2022-enough-to-kill-every-american-says-us-federal-drug-agency-545087">illicit fentanyl</a>. 
&nbsp;

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The United States Food and Drug Administration (FDA), on Friday (July 28) approved the sale of a second opioid overdose reversal drug called RiVive, said the US government agency, in a statement.

The United States Food and Drug Administration (FDA), on Friday (July 28) approved the sale of a second opioid overdose reversal drug called RiVive, said the US government agency, in a statement. It was also the first version of over-the-counter naloxone from a nonprofit company which could lead to cheap and even free doses for those in need. Approval of RiVive The approval of the prescription-free sale of the second opioid overdose reversal drug, RiVive, will provide patients with another over-the-counter option for emergency treatment of known or suspected opioid overdose. The US Centers for Disease Control and Prevention (CDC) recommends quickly administering Narcan – the only over-the-counter FDA-approved option until now – which consists of an active drug called naloxone, a life-saving medication and nasal spray used to counter the overdose effects. ALSO READ | Every 10 hours, one person died due to drug-related overdose, in San Francisco this year: Report Narcan, which was approved in March is available in all 50 states and can be procured without a prescription in most states. Similarly, RiVive, which is also a nasal spray version of the drug naloxone, rapidly reverses or blocks the effects of opioids – especially when administered within minutes of the first signs of an overdose – restoring normal respiration. “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” said FDA Commissioner Robert Califf, in a statement. He added, “The agency has long prioritised access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.” When will it be available? The RiVive’s manufacturer Harm Reduction Therapeutics, a nonprofit pharmaceutical company, said that the opioid overdose reversal drug might be available early next year, primarily to harm-reduction organisations and state governments, reported Reuters. The organisation will also make at least 200,000 doses available for free. ALSO READ | US imposes sanctions on Chinese, Mexican entities in fentanyl action as crisis deepens “If we are able to have partners step forward and help fund our work, we can further lower the cost of RiVive, or increase the amount that we give away for free,” said co-founder and CEO Michael Hufford, as quoted by the news agency. Drug overdose in US RiVive is the second over-the-counter naloxone product approved by the FDA this year. According to the US government agency, more than 105,000 reported fatal overdoses occurred in the 12-month period ending in February 2023. These deaths have predominantly been attributed to synthetic opioids like illicit fentanyl. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

US: FDA approves 'RiVive', second over-the-counter opioid overdose reversal drug

In an effort to streamline the nation's Covid-vaccine approach, the US&nbsp;health authority suggested on Monday (January 23) that healthy adults receive one dose of the most recent updated COVID-19 shot&nbsp;each year, similar to the influenza vaccination campaign.

The US&nbsp;Food and Drug Administration also recommended that its panel coming from external experts explore administering two doses of the Covid&nbsp;vaccine annually to selected young children, elderly people, and those with weakened immune systems. In briefing documents sent before to a meeting of its panel on Thursday, the regulator advocated the necessity of routine selection of variations for upgrading the vaccine, comparable to how strains for flu vaccinations are altered yearly (January 26).

“We need to do something different, because right now it's confusing. The messaging has been very, very mixed and confused about how important the&nbsp;vaccine&nbsp;is," said Dr. Bruce Farber, an infectious disease physician and chief of public health and epidemiology at Northwell Health who spoke to Reuters. "One consistent unified message with a standard schedule I think would make a lot of sense," she added.

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The FDA thinks that yearly immunisation schedules would help make vaccine deployment less difficult and result in fewer vaccine delivery errors and higher vaccination coverage rates. After announcing its plan to revise last month, the agency's proposal was in line with expectations.

Additionally, the Biden administration has been conducting a booster vaccination programme each fall.

Currently, the majority of people in the United States must receive the initial Covid&nbsp;vaccination in two doses, at least three to four weeks apart from one another, and then a booster dose a few months later.

(With inputs from agencies)

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In an effort to streamline the nation's Covid-vaccine approach, the US health authority suggested on Monday (January 23) that healthy adults receive one dose of the most recent updated COVID-19 shot each year, similar to the influenza vaccination campaign.

In an effort to streamline the nation's Covid-vaccine approach, the US health authority suggested on Monday (January 23) that healthy adults receive one dose of the most recent updated COVID-19 shot each year, similar to the influenza vaccination campaign. The US Food and Drug Administration also recommended that its panel coming from external experts explore administering two doses of the Covid vaccine annually to selected young children, elderly people, and those with weakened immune systems. In briefing documents sent before to a meeting of its panel on Thursday, the regulator advocated the necessity of routine selection of variations for upgrading the vaccine, comparable to how strains for flu vaccinations are altered yearly (January 26). “We need to do something different, because right now it's confusing. The messaging has been very, very mixed and confused about how important the vaccine is," said Dr. Bruce Farber, an infectious disease physician and chief of public health and epidemiology at Northwell Health who spoke to Reuters. "One consistent unified message with a standard schedule I think would make a lot of sense," she added. Also read | Study reveals the relationship between antidepressants and 'emotional blunting' The FDA thinks that yearly immunisation schedules would help make vaccine deployment less difficult and result in fewer vaccine delivery errors and higher vaccination coverage rates. After announcing its plan to revise last month, the agency's proposal was in line with expectations. Additionally, the Biden administration has been conducting a booster vaccination programme each fall. Currently, the majority of people in the United States must receive the initial Covid vaccination in two doses, at least three to four weeks apart from one another, and then a booster dose a few months later. (With inputs from agencies) WATCH WION LIVE HERE:

US: FDA proposes once-a-year Covid shots as part of a major shift in the nation's vaccine strategy

Making basic healthcare facilities available to all, the US Food and Drug Administration on Tuesday announced it had signed the historic legislation that allows millions of Americans to buy hearing aids without any prescription, from over-the-counter.

Making basic healthcare facilities available to all, the US Food and Drug Administration on Tuesday announced it had signed the historic legislation that allows millions of Americans to buy hearing aids without any prescription, from over-the-counter. Up until now, the devices were not accessible if an individual did not have a medical subscription. Moreover, only a handful of retail stores sold the device, making accessibility a major issue. Reportedly, FDA changing the rules is expected to benefit nearly 30 million American adults. According to FDA, the finalised rules will reduce the red tapism in the industry. Moreover, it will allow a new class of hearing aids in the market which would not require any standard medical exam or a prescription from a doctor. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Xavier Becerra, Health and Human Services Secretary was quoted as saying by AP. According to FDA estimates, of the 30 million Americans that need hearing devices, only 600,000 or one-fifth use the device, with the rest not willing to take the tedious doctor's prescription route. Not to forget, the devices are not cheap. A single pair of hearing aid and their fitting cost as much as $5,000 which puts a heavy dent in the patient's wallet and in most cases, is not covered under health insurance. Read More: After Juul e-cigarettes, Americans rally behind 'candy' flavoured disposable e-cigs FDA believes that the decentralisation of the process ought to bring the cost down as traditional manufacturers are expected to scale their operations. Experts predict that the hearing market, after the implementation of the new legislation, in a few years will resemble the eye care market where consumers are spoiled for choices and don't have to necessarily rely on prescriptions and medical exams. However, few caveats have been applied to make sure that patients do not come in harm's way. The new over-the-counter status won't apply to devices that are expected to be used by patients with severe hearing loss. Only a prescription will work in such cases. (With inputs from agencies) WATCH WION LIVE HERE:

Americans can buy hearing aids over-the-counter; FDA clears the way

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses.

Watch |&nbsp;WION Fineprint | US approves eye drops that could replace reading glasses

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This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application.

According to the report, the medication is a formulated form of the well-known compound known as&nbsp;pilocarpine, and the researchers have developed&nbsp;it to&nbsp;quickly adapt to the pH of the tear film.

Also read |&nbsp;<a href="https://www.wionews.com/world/how-much-alcohol-to-drink-at-what-age-the-lancet-study-reveals-497554" hreflang="en">How much alcohol to drink at what age? The Lancet study reveals</a>

Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision.

The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants.

Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness.

(With inputs from agencies)

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For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you.

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses. Watch | WION Fineprint | US approves eye drops that could replace reading glasses This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application. According to the report, the medication is a formulated form of the well-known compound known as pilocarpine, and the researchers have developed it to quickly adapt to the pH of the tear film. Also read | How much alcohol to drink at what age? The Lancet study reveals Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision. The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants. Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness. (With inputs from agencies) Watch WION LIVE HERE: You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

US FDA approves new eye drops that can replace spectacles and fix near-vision

Moderna&nbsp;Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.

The US biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the US Centers for Disease Control and Prevention (CDC) and health care providers.

Moderna's request is significantly broader than Pfizer Inc and its German partner BioNTech SE's application that was filed earlier this week with US regulators for a second booster shot for people aged 65 and older.

Also read |&nbsp;<a href="https://www.wionews.com/world/britain-approves-astrazenecas-preventative-covid-therapy-463272">Britain approves AstraZeneca's preventative COVID therapy</a>

Moderna, without specifically commenting on the effectiveness of a fourth shot, said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant.

FDA did not immediately respond to a Reuters request for comment.

US health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth shot, especially for older people and to prepare for the possibility of another surge in cases.

Also read |&nbsp;<a href="https://www.wionews.com/world/once-pledged-to-keep-covid-vaccine-patent-free-moderna-signals-to-enforce-patent-460237">Moderna once pledged to keep Covid vaccine patent-free. Now it's changing course</a>

CDC data has shown that vaccine efficacy wanes over time and a third shot helps restore it. It, however, has not released comprehensive data based on age or health status to back the case.

The news was first reported by the New York Times.

While COVID cases are falling in the United States and much of the world, infections are rising in China. In the UK and Europe, there has been a reversal in the downward trend of COVID cases as economies have opened up and a second variant of Omicron circulates.

Watch |&nbsp;Gravitas: Global covid cases are rising again

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Moderna Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic.

Moderna Inc on late Thursday (March 17) sought emergency use authorisation with US health regulators for a second COVID-19 booster shot, as a surge in cases in some parts of the world fuels fears of another wave of the pandemic. The US biotechnology company said its request covered all adults over the age of 18 so that the appropriate use of an additional booster dose of its vaccine, including for those at higher risk of COVID-19 due to age or comorbidities, could be determined by the US Centers for Disease Control and Prevention (CDC) and health care providers. Moderna's request is significantly broader than Pfizer Inc and its German partner BioNTech SE's application that was filed earlier this week with US regulators for a second booster shot for people aged 65 and older. Also read | Britain approves AstraZeneca's preventative COVID therapy Moderna, without specifically commenting on the effectiveness of a fourth shot, said its submission was partly based on data recently published in the United States and Israel following the emergence of the Omicron variant. FDA did not immediately respond to a Reuters request for comment. US health officials, including top infectious disease expert Dr. Anthony Fauci, have raised the prospect of a fourth shot, especially for older people and to prepare for the possibility of another surge in cases. Also read | Moderna once pledged to keep Covid vaccine patent-free. Now it's changing course CDC data has shown that vaccine efficacy wanes over time and a third shot helps restore it. It, however, has not released comprehensive data based on age or health status to back the case. The news was first reported by the New York Times. While COVID cases are falling in the United States and much of the world, infections are rising in China. In the UK and Europe, there has been a reversal in the downward trend of COVID cases as economies have opened up and a second variant of Omicron circulates. Watch | Gravitas: Global covid cases are rising again

Moderna seeks FDA authorisation for second COVID-19 booster for all adults

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US.

Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States."

"The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said.

Also read |&nbsp;<a href="https://www.wionews.com/world/5-billion-ppe-items-worth-ps27-billion-will-go-waste-reveals-uk-government-449112" hreflang="en">5 billion PPE items worth £2.7 billion will go waste, reveals UK government</a>

Age 18 or older is the minimum requirement for obtaining the Moderna vaccine.

A Pfizer's vaccine for individuals aged 16 or older was approved by the FDA at the end of August.

Woodcock expressed the hope that FDA approval of the Moderna vaccine will help more people feel at ease and "may instill additional confidence in making the decision to get vaccinated."

The FDA move was deemed a "momentous milestone" for the company by CEO Stephane Bancel.

"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," Bancel said in a statement.

Also read |&nbsp;<a href="https://www.wionews.com/science/us-scientists-come-up-with-cheap-covid-test-relying-on-low-tech-kit-smartphone-find-out-how-does-it-work-448699" hreflang="en">US scientists come up with cheap Covid test relying on low-tech kit, smartphone. Find out how does it work</a>

The Moderna vaccine was approved for emergency use in December 2020.

Moderna has full FDA approval for only the first two doses, emergency use authorisation&nbsp;remains in effect for the booster dose.

A clinical trial that evaluated the effectiveness of Spikevax involved 14,287 vaccination recipients and 14,164 placebo recipients, according to the FDA.

In clinical trials, participants reported pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea and vomiting, and swollen lymph nodes as the most common side effects.

Watch |&nbsp;Gravitas: Wuhan scientists flag deadlier coronavirus

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According to the FDA, men aged 18 to 24 were said to be more likely to develop myocarditis or inflammation of the heart muscle, and pericarditis, or inflammation of the surrounding tissue, following vaccination with the second dose.

Despite this, the FDA said it had determined that the "benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older."

(With inputs from agencies)

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US.

Moderna's COVID-19 "Spikevax" vaccine received full approval from the US Food and Drug Administration (FDA) on Monday. It had previously been authorized for emergency use in the US. Janet Woodcock, the acting FDA commissioner, said in a statement that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States." "The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," Woodcock said. Also read | 5 billion PPE items worth £2.7 billion will go waste, reveals UK government Age 18 or older is the minimum requirement for obtaining the Moderna vaccine. A Pfizer's vaccine for individuals aged 16 or older was approved by the FDA at the end of August. Woodcock expressed the hope that FDA approval of the Moderna vaccine will help more people feel at ease and "may instill additional confidence in making the decision to get vaccinated." The FDA move was deemed a "momentous milestone" for the company by CEO Stephane Bancel. "Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," Bancel said in a statement. Also read | US scientists come up with cheap Covid test relying on low-tech kit, smartphone. Find out how does it work The Moderna vaccine was approved for emergency use in December 2020. Moderna has full FDA approval for only the first two doses, emergency use authorisation remains in effect for the booster dose. A clinical trial that evaluated the effectiveness of Spikevax involved 14,287 vaccination recipients and 14,164 placebo recipients, according to the FDA. In clinical trials, participants reported pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea and vomiting, and swollen lymph nodes as the most common side effects. Watch | Gravitas: Wuhan scientists flag deadlier coronavirus According to the FDA, men aged 18 to 24 were said to be more likely to develop myocarditis or inflammation of the heart muscle, and pericarditis, or inflammation of the surrounding tissue, following vaccination with the second dose. Despite this, the FDA said it had determined that the "benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older." (With inputs from agencies)

Moderna's 'Spikevax' coronavirus vaccine gets full FDA approval in US

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a>, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among <a href="https://www.wionews.com/topics/coronavirus-vaccine">Coronavirus</a> patients by 85 per cent and is also effective against the variants. 
 
The drug Sotrovimab has been given an emergency use authorisation (EUA) for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older, weighing at least 40 kg.

Also Read |&nbsp;<a href="https://www.wionews.com/world/seeking-a-pill-to-cure-covid-drugmakers-eye-alternative-to-vaccines-387717">Seeking a pill to cure Covid: Drugmakers eye alternative to vaccines</a> 
 
The drug has shown positive results among patients 65 years of age and older or individuals who have certain medical conditions and are at high risk for progression to severe COVID-19, including hospitalisation or death. 
 
Laboratory tests have shown that Sotrovimab is able to neutralise the current circulating variants of Covid first reported in the UK, South Africa, Brazil, California, New York and India.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/black-fungus-drug-amphotericin-b-to-be-priced-at-rs-1200-for-each-vial-in-india-387750">Black fungus drug Amphotericin B to be priced at Rs 1200 for each vial in India</a> 
 
"With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital," Patrizia Cavazzoni, Director of the FDA`s Center for Drug Evaluation and Research, said in a statement on Wednesday. 
 
"It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States," Cavazzoni added.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/modernas-single-dose-vaccine-in-india-likely-next-year-pfizer-ready-with-50-mn-doses-for-2021-387438">Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021</a> 
 
However, Sotrovimab is not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to the disease, the FDA said. 
 
This treatment has not shown benefit in patients hospitalised due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalised patients requiring high flow oxygen or mechanical ventilation.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/as-india-is-troubled-with-fresh-covid-wave-a-drug-and-therapy-bring-hope-379586">As India is troubled with fresh Covid wave, a drug and therapy bring hope</a> 
 
Monoclonal antibodies are laboratory-made proteins that mimic the immune system`s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of <a href="https://www.wionews.com/topics/coronavirus">SARS-CoV-2</a> and is designed to block the virus` attachment and entry into human cells. 
 
The EUA is based on an interim analysis from a Phase 1/2/3 randomised, double-blind, placebo-controlled clinical trials in 583 non-hospitalised adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result.

Also Read |&nbsp;<a href="https://www.wionews.com/world/drug-prevents-coronavirus-infection-in-nursing-homes-maker-claims-358546">Drug prevents coronavirus infection in nursing homes, maker claims</a> 
 
Of these patients, 291 received Sotrovimab and 292 received placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalisation for greater than 24 hours for acute management of any illness or death from any cause) through day 29. 
 
Hospitalisation or death occurred in 21 (7 per cent) patients who received placebo compared to 3 (1 per cent) patients treated with Sotrovimab, an 85 per cent reduction.

Also Read |&nbsp;<a href="https://www.wionews.com/world/us-grants-emergency-use-authorisation-to-regeneron-covid-19-antibodies-344588">US grants emergency use authorisation to Regeneron Covid-19 antibodies</a> 
 
The drug will be distributed and administered as a 500 milligram single dose intravenously by health care providers. Potential side effects of Sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhoea, the FDA said.

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against COVID-19, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among Coronavirus patients by 85 per cent and is also effective against the variants.

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against COVID-19, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among Coronavirus patients by 85 per cent and is also effective against the variants. The drug Sotrovimab has been given an emergency use authorisation (EUA) for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older, weighing at least 40 kg. Also Read | Seeking a pill to cure Covid: Drugmakers eye alternative to vaccines The drug has shown positive results among patients 65 years of age and older or individuals who have certain medical conditions and are at high risk for progression to severe COVID-19, including hospitalisation or death. Laboratory tests have shown that Sotrovimab is able to neutralise the current circulating variants of Covid first reported in the UK, South Africa, Brazil, California, New York and India. Also Read | Black fungus drug Amphotericin B to be priced at Rs 1200 for each vial in India "With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital," Patrizia Cavazzoni, Director of the FDA`s Center for Drug Evaluation and Research, said in a statement on Wednesday. "It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States," Cavazzoni added. Also Read | Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021 However, Sotrovimab is not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to the disease, the FDA said. This treatment has not shown benefit in patients hospitalised due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalised patients requiring high flow oxygen or mechanical ventilation. Also Read | As India is troubled with fresh Covid wave, a drug and therapy bring hope Monoclonal antibodies are laboratory-made proteins that mimic the immune system`s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus` attachment and entry into human cells. The EUA is based on an interim analysis from a Phase 1/2/3 randomised, double-blind, placebo-controlled clinical trials in 583 non-hospitalised adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Also Read | Drug prevents coronavirus infection in nursing homes, maker claims Of these patients, 291 received Sotrovimab and 292 received placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalisation for greater than 24 hours for acute management of any illness or death from any cause) through day 29. Hospitalisation or death occurred in 21 (7 per cent) patients who received placebo compared to 3 (1 per cent) patients treated with Sotrovimab, an 85 per cent reduction. Also Read | US grants emergency use authorisation to Regeneron Covid-19 antibodies The drug will be distributed and administered as a 500 milligram single dose intravenously by health care providers. Potential side effects of Sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhoea, the FDA said.

US FDA authorises GSK-Vir monoclonal antibody drug for Covid

US experts will meet Thursday to decide whether to recommend approval of Moderna's Covid-19 vaccine for emergency use.

Moderna vaccine inches closer to emergency use approval in United States

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Americans can buy hearing aids over-the-counter; FDA clears the way

US FDA approves new eye drops that can replace spectacles and fix near-vision

Moderna seeks FDA authorisation for second COVID-19 booster for all adults

Moderna's 'Spikevax' coronavirus vaccine gets full FDA approval in US

US FDA authorises GSK-Vir monoclonal antibody drug for Covid

Moderna vaccine inches closer to emergency use approval in United States