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.
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 ...
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 ...
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 ...
STAT11h
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 ...
FierceBiotech19h
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
The biotech engaged with the FDA on alternative pathways to approval after seeing safety and efficacy data from the phase 1/2 ...
BioPharma Dive14h
FDA names Tarver as new head of device center
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
STAT18h
Michelle Tarver to lead FDA medical device center
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an ...
MassDevice15h
iRhythm stock soars on FDA nod for changes to Zio AT following warning letter
Rhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance related to design changes made to its ...
Antidepressant recall: FDA upgrades medication risk class to 2nd highest level in recall update
The U.S. Food and Drug Administration is urging patients not to stop taking their prescribed medication if it falls under the ...
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 ...