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.
The U.S. Food and Drug Administration on Tuesday approved Pfizer's RSV vaccine for the prevention of lower respiratory tract ...
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 ...
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
The biotech engaged with the FDA on alternative pathways to approval after seeing safety and efficacy data from the phase 1/2 ...
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an ...
The Food and Drug Administration, in collaboration with the U.S. Customs and Border Protection (CBP), seized about three ...
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
Peytant Solutions has received marketing authorisation from the US Food and Drug Administration (FDA) for its AMStent ...