The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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

The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased ...

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.

Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...

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

Shares of Klotho Neurosciences, Inc. (NASDAQ:KLTO) surged 22% following news that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s gene therapy ...

Soleno Therapeutics's previously-announced public offering of 2.35 million shares was priced at $85 apiece, resulting in $200 million in proceeds. The biopharmaceutical company said on Thursday that ...

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...