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 ...
(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 ...
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 ...
Please provide your email address to receive an email when new articles are posted on . The FDA was not concerned about the drug’s pharmacokinetics. Concerns included packaging, patient use and ...
Abbott is facing a warning letter from FDA regarding its Freestyle Libre family of continuous glucose monitoring (CGM) devices for use in diabetes management. The agency said it received responses ...
No one working in the medical device industry is a stranger to FDA warning letters. Every month, FDA compiles a list of infractions from the last 30 days, routinely naming major companies like Abbott, ...
Beta Bionics received the warning letter on Jan. 29. It follows a Form 483 that the company received last year after an inspection of its facility in Irvine, California, between June 9 and June 26.
Jan 30 (Reuters) - Shares of Corcept Therapeutics (CORT.O), opens new tab fell 16% on Friday after a corrected "complete response letter" from the U.S. Food and Drug Administration showed the agency ...
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review process Company expects to submit updates to the BLA in February 2026 to support continued FDA review SAN DIEGO, Jan.
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