FDA releases the form FDA-483 containing eight observations from an inspection at the Sun Pharmaceutical drug manufacturing facility in Halol, Gujarat...
Researchers, including CBER director Vinay Prasad, call for incentivized or mandated head-to-head randomized controlled trials of follow-on oncology d...
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...
