The FDA is reportedly weighing adding high-level warning labels to COVID vaccines, a move that some experts say may cause ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

Dozens of units of counterfeit Ozempic (semaglutide 1mg injection) were seized by the FDA, according to a drug safety alert issued by the Agency.

Shares in Sarepta reversed some of their recent declines after the FDA added a warning label to its Duchenne muscular dystrophy (DMD) gene therapy, ending a protracted period of uncertainty for the ...

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...

More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one backdated for November 24 for Daiichi Sankyo’s tenosynovial giant cell ...

" It sounds wholesome, right? Pure. Like something your grandmother might have used in her kitchen. The clean label movement has exploded in recent years, with half of industry professionals ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...