Three stakeholders comment and make recommendations following an FDA listening session on methods and approaches for capturing post-approval safety an...
Federal Register notice: FDA determines that a Fresenius Kabi NDA for heparin sodium injection was not withdrawn for reasons of safety or effectivenes...
Germany-based Berlin Heart recalls its Excor Pediatric Ventricular Assist Device Blood Pumps due to the potential for therapy disruption.
FDA accepts for priority review a Takeda and Hutchmed NDA for fruquintinib, indicated for treating adult patients with previously treated metastatic c...
Elon Musks Neuralink says FDA has approved a human trial for its brain implant technology to be used to control external technology.
FDA approves a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitaliz...
Federal Register notice: FDA determines that Purdue Pharmas Chirocaine (levobupivacaine) injection was not withdrawn due to safety or effectiveness re...
Mirati Therapeutics says its sitravatinib failed to meet the primary endpoint in the Phase 3 SAPPHIRE lung cancer study.
