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FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.[ Price : $8.95]
FDA posts a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Drug-Drug Interaction (DDI) Assessment for Therapeutic Prot...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome: Establ...[ Price : $8.95]
FDA removes a two-month-long partial clinical hold on a Molecular Templates Phase 1 multiple myeloma study of MT-0169 that was bas...[ Price : $8.95]
Senator Dick Durbin (D-IL) urges FDA to do more to improve supply shortages of critical cancer drugs.[ Price : $8.95]
FDA grants Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for tr...[ Price : $8.95]
FDA posts a final guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.