FDA grants Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adults with relapsed o...
Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from fraudulent vaccine tr...
FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approved pediatric disease...
FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respiratory infections and co...
FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.
United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredients to Liquidia is ...
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for its Dsuvia opioid pai...
