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FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.[ Price : $8.95]
FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...[ Price : $8.95]
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...[ Price : $8.95]
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.[ Price : $8.95]
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...[ Price : $8.95]
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...[ Price : $8.95]
CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...