RSV, Pfizer and FDA

FDA approves Pfizer's RSV shot Abrysvo for all at-risk adults
While it’s a win for Pfizer over GSK and its RSV vaccine Arexvy, which is approved for those 50 and older, it’s difficult to determine how much advantage will be gained from the nod as the Centers for Disease Control (CDC) will have to sign off on Abvrysvo's use in the wider age group.
US FDA approves Pfizer's RSV vaccine for adults at increased risk of the disease
The U.S. Food and Drug Administration on Tuesday approved Pfizer's RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease.
Pfizer Wins FDA Approval of RSV Vaccine for Broader Adult Population
Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.
Pfizer announces FDA approval of Abrysvo
Pfizer (PFE) announced that the U.S. FDA has approved Abrysvo, the company’s bivalent RSV prefusion F vaccine, for the prevention of
Pfizer Receives FDA Approval for RSV Vaccine
Abrysvo can prevent lower respiratory tract disease caused by RSV for people between the ages of 18 and 59 who are at increased risk. It is the first RSV vaccine indicated for adults younger than 50,
Pfizer RSV vaccine Abrysvo gains expanded indication
The U.S. FDA has approved Pfizer's respiratory syncytial virus vaccine Abrysvo for individuals 18 to 59 years old that are at increased risk of lower respiratory tract disease from the virus. Those conditions include obesity,
Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies
The Danish drugmaker Novo Nordisk argues that semaglutide, the active ingredient in Ozempic and Wegovy, are too complex for ...
FDA Has Recalled Thousands of Bottles of Antidepressant Duloxetine, Sold Under Brand Name Cymbalta: Here’s Why
The U.S. Food and Drug Administration has recalled thousands of bottles of the antidepressant Duloxetine (sold under the ...
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Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which ...
FDA says this weight loss drug shortage is over, but patients worry about cost and availability
Some patients fear tirzepatide, sold by Eli Lilly under the brand names Zepbound and Mounjaro, will be hard to get and prohibitively expensive once compounding pharmacies are no longer producing it.
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FDA and Industry Experts Unpack Biosimilar Device Requirements
At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for ...
Dog Medicine Recall Update As FDA Sets Risk Class
A class II risk level is given to products that "may cause temporary or medically reversible adverse health consequences." ...
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7,100 bottles of antidepressant recalled by FDA now in 2nd highest risk class
Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.
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Novo asks FDA to bar compounders from making Ozempic copies
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...
Juice Drinks Recall Update as FDA Sets Risk Level
In an update issued on Tuesday, the FDA classed the recalls as Class II, which is when the "use of or exposure to a violative product may cause temporary or medically reversible adverse health ...
FDA grants marketing authorisation to Peytant’s AMStent system
Peytant Solutions has received marketing authorisation from the US Food and Drug Administration (FDA) for its AMStent ...