FDA releases hiring data showing steep declines in staffing at CDER and CBER.
FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.
GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infecti...
FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intravenously.
FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the risk of medication er...
FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic contact dermatitis.
FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma i...
Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used in combination with...
