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FDA places a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death...[ Price : $8.95]
FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.[ Price : $8.95]
FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for tr...[ Price : $8.95]
FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.[ Price : $8.95]
FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stop...[ Price : $8.95]
FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally ster...[ Price : $8.95]
FDA grants Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating sm...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represente...