Federal Register notice: FDA makes available a draft guidance entitled Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologi...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.
FDA publishes a draft guidance to help sponsors of some products regulated by CDER and CBER perform nonclinical safety evaluations of the products imm...
Former FDA attorney William McConagha moves from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation and enforcement pract...
Federal Register notice: FDA announces a 4/21 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Tre...