Rapt Therapeutics terminates its zelnecirnon drug development program due to a serious liver safety issue.
FDA grants Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating Sjgren's disease.
AbbVie says its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia did not...
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.
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...
