The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.

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

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

The new method is intended to create a clearer, more practical process — one that could make custom treatments more available to patients who desperately need them. FDA officials stressed that these ...

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 ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

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.

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...