Food and Drug Administration on Tuesday requested companies to remove warnings related to the potential risk of suicidal ...
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
The U.S. FDA on Tuesday requested Novo Nordisk (NVO) and Eli Lilly (LLY) to implement labeling changes for their blockbuster ...
Three dietary supplements were recalled across the United States last week due to undeclared ingredients that could raise ...
The U.S. Food and Drug Administration approved Fortress Biotech and Indian drugmaker Zydus Lifesciences' drug for children ...
Less than four months after rejecting Sentynl Therapeutics and Cyprium Therapeutics’ treatment for Menkes disease, the FDA ...
Martin Makary, commissioner of the Food and Drug Administration, on the push against ultra processed foods and added sugar, ...
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FDA Issues Highest Risk Level for Nationwide Cheese Recall—Products May Be Contaminated With Listeria
The recalled Pecorino Romano cheese tested positive for Listeria, one of the deadliest pathogens that causes foodborne ...
The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
The Food and Drug Administration has upgraded a recall to the highest danger level after several cheese products tested positive for listeria.Specific cheese<a class="excerpt-read-more" href=" More ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin ...
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