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- FDA Issues Final Guidance on Prescription Drug Apps and SoftwareThe U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription m…fda press · 1h ago↗ source
- FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal CancerThe U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…