The FDA already authorizes the use of experimental drugs under what’s called “compassionate use,” for people with no other ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...

The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a streamlined pathway for bespoke therapies that could address unmet medical needs.

Federal health officials yesterday issued a proposal that would make it easier for patients with rare diseases to receive treatment.

“It is our priority to remove barriers and exercise regulatory flexibility to encourage scientific advances and deliver more cures and meaningful treatments for patients suffering from rare diseases,” ...

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for psychedelic drugs, a move that directly clears a path for psilocybin, the active ...