FDA approves Hikmas liraglutide injection, the first generic form of Novo Nordisks Victoza it has approved.
FDA approves an expanded indication for Rhythms Imcivree to include pediatric patients as young as age 2.
FDA approves Ionis Tryngolza as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.
FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...
Federal Register notice: FDA makes available a final guidance entitled Advanced Manufacturing Technologies (AMT) Designation Program.
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.
