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

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...

In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters ...

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

Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and ...

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 ...

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 deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and ...

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