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FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 ...[ Price : $8.95]
FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility ci...[ Price : $8.95]
Florida amends a lawsuit against FDA charging the agency with violating the Freedom of Information Act by withholding records requ...[ Price : $8.95]
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...