FDA releases summaries from three PDUFA 7 workgroup and subgroup discussions at the end of 2020.
FDA approves a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncompl...
CBER says it plans to issue 14 guidances in three categories in the current calendar year.
FDA approves Galdermas Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.
FDA clears an NGMedical 510(k) for its 3D-manufactured titanium cervical interbody BEE cage implant.
FDA warns American Global Health Group that it is marketing misbranded unapproved new drugs.
FDA clears NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead (XXX DELETE XXX) drug candidate, NE3107 in Alzheimers disease pati...
Eagle Pharmaceuticals says it is responding to an FDA complete response letter for its vasopressin ANDA.