Listeriosis, the condition caused by listeria infection, causes headaches, fever, muscle aches, confusion and diarrhea among ...
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
The U.S. health regulator on Tuesday asked drugmakers to remove label warnings about a potential risk of suicidal thoughts ...
Stocktwits on MSN
FDA clears popular weight-loss drugs of suicide risk after review of over 100K patients, asks drugmakers to remove warnings
The decision follows a comprehensive review that found no link between GLP-1 RA use and suicidal ideation or behavior. ・The ...
Martin Makary, commissioner of the Food and Drug Administration, on the push against ultra processed foods and added sugar, ...
Health on MSN
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 U.S. Food and Drug Administration approved Fortress Biotech and Indian drugmaker Zydus Lifesciences' drug for children ...
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 ...
Less than four months after rejecting Sentynl Therapeutics and Cyprium Therapeutics’ treatment for Menkes disease, the FDA ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
FDA officials explain that tianeptine can cause "life-threatening events" like "suicidal ideation" or behavior in children, ...
In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...
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