FDA panel rejects only 1 peptide
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The Food and Drug Administration responded to a health policy group requesting clear enforcement of alternative funding programs, or AFPs. The agency reiterated its regulation against the foreign importation of drugs, but declined to issue specific guidance.
The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines the Trump administration deems as "supporting U.S ...
Treatments for fibrodysplasia ossificans progressiva, gastroenteropancreatic neuroendocrine tumors, HIV, influenza, and multiple myeloma are under review.
Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the pharmaceutical industry has long considered unprofitable.
Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna’s seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed. In an all-day meeting ...