AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small cell lung cancer.
The Washington DC District Court rejects a Novartis motion in a generic drug carve-out case for a preliminary injunction to stay FDAs approval of MSN ...
Federal Register notice: FDA withdraws approval of Cubist Pharmaceuticals Entereg (alvimopan) capsules because it is no longer marketed.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bausch + Lombs eye drug Miebo (perfluorohexyloc...
Federal Register notice: FDA debars Ryan Stabile for 15 years from importing or offering for import any drug into the U.S.
Two Sheppard Mullin attorneys say sponsors of drugs approved through expedited pathways should learn from a recent FDA untitled letter faulting Mirais...
FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of care.
FDA describes CDERs new state-of-the-art advanced manufacturing research facility.
