FDA, Cymbalta

FDA says this weight loss drug shortage is over

FiercePharma12m
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 ...
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 ...
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 ...
BioSpace1h
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 ...
centerforbiosimilars37m
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." ...
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 ...
STAT15h
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 ...