BD and subsidiary CareFusion issue an Urgent Medical Device Recall (Correction) letter related to performance issues involving the BD Alaris Pump Modu...
CBER director Vinay Prasad again overrides career staff to limit a Covid vaccines use, according to a just-posted decisional memo.
FDA issues Ultragenyx Pharmaceutical a complete response letter on its BLA for UX111 (ABO-102), an investigational gene therapy for Sanfilippo syndrom...
Atara Biotherapeutics resubmits its BLA for Ebvallo (tabelecleucel or tab-cel), seeking approval for its use as monotherapy for treating Epstein-Barr ...
FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decisio...
FDA approves a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular death, hospitalization f...
Edwards Lifesciences recalls its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the ou...
FDA leaders say that the agency is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 severe outcomes and the l...
