The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good ...
MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
Pharmaceutical Technology on MSN
Atara receives FDA complete response letter for Ebvallo BLA application
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...
Atara Biotherapeutics stock drops on FDA rejection of EBVALLO BLA for serious post-transplant complication. FDA raises new concerns.
The market opportunity lies in providing specialized GMP auditing courses to pharmaceutical professionals, enhancing their skills in compliance, evaluation, and reporting, thereby ensuring ...
The market opportunity lies in providing comprehensive training on GMP compliance for dietary supplements, highlighting FDA regulations, safety, and quality improvements. Bridging the knowledge gap ...
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