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 ...

The U.S. Food and Drug Administration issued its first formal guidance on how to design and run clinical trials for ...

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

Compass Pathways announced that its investigational psilocybin treatment has successfully met its primary endpoint in a Phase 3 trial in depression.

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

Optune Pax® with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.

Reversing its initial decision, the FDA has agreed to review Moderna’s messenger RNA-based influenza vaccine for approval, the company announced Wednesday. The reversal about weeks after the FDA sent ...

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...