FDA removes a two-month-long partial clinical hold on a Molecular Templates Phase 1 multiple myeloma study of MT-0169 that was based on cardiac advers...
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FDA publishes a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.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...
