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.
Congressman Jason Crow (D-CO) leads a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrophic Lateral Sclerosi...
A new combination therapy involving AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentechs Perjeta) shows signifi...
FDA releases its FY 2026 budget proposal showing that the agencys overall budget would decrease by 4% ($271 million) to $6.8 billion beginning 10/1.
