Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to hear a laboratory research ov...
FDA plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of next month.
A new report from FDA examines pediatric labeling on orphan drugs that were approved from 4/1/1999 to 8/31/2018.
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanaf...
FDA says it wants to start seeing more males included in breast cancer drug trials and using real world data can help.
FDA approves an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic rhinitis and perenni...
FDA clears a Vyaire Medical 510(k) for two of its latest pulmonary function testing technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software...
Oklahoma county judge Thad Balkman rules against Johnson & Johnson and orders it to pay $572 million in the first ruling in the U.S. holding a drugmak...