Senator Dick Durbin (D-IL) urges FDA to do more to improve supply shortages of critical cancer drugs.
FDA grants Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for treating patients with...
FDA posts a final guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.
FDA releases a final guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
FDA releases a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.
FDA publishes a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longe...
FDA approves Pfizers Abrysvo vaccine to prevent respiratory syncytial virus in older adults.
