FDA grants priority review to a BioMarin investigational gene therapy for hemophilia A.
FDA approves a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain.
Federal Register notice: FDA reopens the comment period for an 11/20/2019 notice seeking comments on Guidance for Industry #256 Compounding Animal Dr...
Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologi...
Bristol-Myers Squibb says a Phase 2 trial of cabiralizumab in patients with advanced pancreatic cancer did not meet its primary endpoint.
University researchers say that FDA was late in ordering mesh implants used in pelvic organ prolapse from the market, possibly due to positive patient...
CDRH and CDER launch a new Web resource to provide the current science on gene-drug associations.
Sen. Grassley predicts that his bipartisan drug pricing legislation will pass by 5/20.