FDA accepts for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locall...
FDA grants Ironwood Pharmaceuticals an orphan drug designation for olinciguat (IW-1701) for treating patients with sickle cell disease.
Former Office of New Drugs director John Jenkins joins the Corbus Pharmaceuticals board.
Federal Register notice: FDA corrects a 2/23 notice announcing that Sun Pharmaceutical Industries asked to withdraw its generic benazepril hydrochlori...
FDA rejects Mylan/Biocons biosimilar application for a Lantus follow-on due to manufacturing site questions.
FDA files a complaint seeking a permanent injunction against Innovative BioDefense (Lake Forest, CA) and president/CEO Colette Cozean to prohibit them...
FDA issues a guidance on circumstances in which an NDA applicant may be eligible for a barrier-to-innovation PDUFA waiver for fixed-combination and si...
FDA issues a draft guidance updating mechanisms available to submitters to request agency feedback or a meeting on a variety of medical device applica...