FDA warns Dr. Mark Savant and his San Francisco Research Institute about bioresearch monitoring violations in his conduct of a clinical investigation.
FDA approves a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product Kirsty (insulin aspart-xjhz).
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 ...
