Marty Makary appeared for Thursday an interview on CNBC to tout efforts under his leadership at the Food and Drug Administration to speed up approvals for treatments of rare diseases. Instead, he ...
This week’s Capitol Hill meetings come on the heels of rejections of ultra-rare disease drugs developed by Biohaven and Saol Therapeutics. Physicians and patient groups implored the FDA to expedite ...
The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...
The U.S. Food and Drug Administration announced a Class I recall this week for frozen blueberries. Cases were sent to ...
Video above: ‘News 5 Now’ — Top Stories from Feb. 12, 2026 ALABAMA (WRBL) — The Alabama Public Service Commission (PSC) announced Thursday that the scheduled implementation of a new area code will ...
A photo of pepperoni sausage slices stacked in unbranded, vacuum-sealed packages. The US Food and Drug Administration is reassessing the safety of butylated hydroxyanisole, a preservative commonly ...
ISELIN, N.J., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of ...
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling. The FDA’s stunning decision to ...
(CNN) — The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the ...
The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company said. It's another sign of the Trump administration's influence on ...
During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. Now, with a refusal-to ...
A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi. Among ...
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