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.
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.
