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

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 ...

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing Thursday on how the ...

US health officials are proposing a new way to develop and approve custom-made treatments for people with rare and hard-to-treat conditions.

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 ...

"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Montage Systems CEO Eric Collins said during a ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...