FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.
FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of for...
Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims abo...
FDA warns Chinas Taizhou Jingshang Cosmetics Technology Co. about CGMP violations in its production of finished drugs.
The CDER Office of Prescription Drug Promotion hits Mayne Pharma over a professional presentation on Nextstellis that it says makes false and misleadi...
GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain non-small cell lung c...
Former FDA commissioner David Kessler, who is taking one of the new weight loss drugs, calls on FDA to require data to help people come off the drugs ...
FDA clears a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days...
