FDA posts an untitled letter sent to Brookfield Medical/Surgical Supplies due to GMP issues cited in a May inspection.
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.
Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.
Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.
FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia Type 2.
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.
