MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA filings ...

Dec 8 (Reuters) - The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a severe form of fatty liver disease in drug trials, the ...

Applied Therapeutics’ lack of progress on govorestat as well as the potential costs to come have led analysts to question whether the biotech will ever be able to get the drug to market. The New ...

for the Performing Arts prepares to turn the building into a performance space. The bell at Central Presbyterian Church in downtown Columbus may not ring often anymore, but as Jason Gay pulled down on ...

(Corrective Action and Preventive Action) systems for drug, biologic, and medical products. It covers CAPA definitions, principles, regulatory requirements, and Root Cause Analysis (RCA) techniques.

Scholar Rock Holding Inc. (NASDAQ:SRRK) stock is falling on Monday with a session volume of 8.19 million versus the average volume of 2.08 million, as per data from Benzinga Pro. In a press release on ...

SAN FRANCISCO, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcadia Medicine (‘Arcadia’), a company developing safer empathogens to treat mental health disorders, has announced that the United States Food and ...

WASHINGTON — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians ...

The Food and Drug Administration on Tuesday quietly approved a generic form of mifepristone, one of the two medications used in most U.S. abortions. That makes the drug, from the company Evita ...