FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager for t...
FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility cited significant GMP ...
Florida amends a lawsuit against FDA charging the agency with violating the Freedom of Information Act by withholding records requested by the state r...
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 was reported.
FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.
FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for treating invasive aspe...
FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.
FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stopped all operations a...
