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FDA releases the form FDA-483 containing eight observations from an inspection at the Sun Pharmaceutical drug manufacturing facili...[ Price : $8.95]
Researchers, including CBER director Vinay Prasad, call for incentivized or mandated head-to-head randomized controlled trials of ...[ Price : $8.95]
BD and subsidiary CareFusion issue an Urgent Medical Device Recall (Correction) letter related to performance issues involving the...[ Price : $8.95]
CBER director Vinay Prasad again overrides career staff to limit a Covid vaccines use, according to a just-posted decisional memo....[ Price : $8.95]
FDA issues Ultragenyx Pharmaceutical a complete response letter on its BLA for UX111 (ABO-102), an investigational gene therapy fo...[ Price : $8.95]
Atara Biotherapeutics resubmits its BLA for Ebvallo (tabelecleucel or tab-cel), seeking approval for its use as monotherapy for tr...[ Price : $8.95]
FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal S...[ Price : $8.95]
FDA approves a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular deat...