FDA to allow one pivotal trial instead of two for drug approval

The US Food and Drug Administration (FDA) will allow sponsors to file for drug approval with just one pivotal trial instead of two.
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

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 ...
PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

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

Healthy returns: FDA chief Marty Makary on compounded GLP-1s, vaccines and China

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...
WLKY

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

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 ...

Compass Pathways Phase 3 Results Raise Hopes For FDA Approval Of Psilocybin

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

Dr. Goodenowe Dietary Therapeutics LLC announces FDA-governed development pathway for nutrient-based compounds

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

FDA Approves New Treatment for Patients with Locally Advanced Pancreatic Cancer: What You Need to Know

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.