FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.
FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.
Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintain some level of cont...
CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoints for accelerated a...
FDA approves a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive prostate cancer.
FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with relapsed or refractory a...
FDA gives de novo authorization to Clarity Breast which uses artificial intelligence to make a five-year breast cancer risk prediction from a screenin...
FDA deputy commissioner for strategic initiatives Lowell M. Zeta adds Special Counsel for FDA role to his duties.
