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

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

Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.

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 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.

Compass Pathways announced that its investigational psilocybin treatment has successfully met its primary endpoint in a Phase ...