In a major shift, the US Food and Drug Administration is relaxing a long-standing drug approval requirement for common ...

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

The framework was released as draft guidance on February 23.

“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 ...

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 ...

The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a ...

An FDA rejection last year for a rare disease drug from Biohaven reflects the amount of work left to get patients the treatments they need, the company says.