FDA accepts for review a Unicycive Therapeutics 505 (b) (2) NDA for oxylanthanum carbonate and its use in treating hyperphosphatemia patients with chr...
FDA clears a Foundation Surgical 510(k) for its Vertiwedge Intraosseous, a motion-sparing partial vertebral body replacement device.
FDA removes a clinical hold on a Novavax IND for its Covid-19-influenza combination and stand-alone flu vaccine candidates.
FDA approves an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with lymphoblastic leukem...
Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use for treating adult patients with high-...
FDA clears a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography.
Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, but the results also s...
Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.
