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- FDA releases final guidance on prescription-drug companion apps and softwareFDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
- 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…