The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...

The Food and Drug Administration (FDA) took action against Ajanta Caterers. This followed a video showing a legislator ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...