Medicus Pharma is prioritizing clinical milestones, regulatory progress and potential partnerships across its oncology, ...

The U.S. Food and Drug Administration (FDA) has accepted XCath’s Iris Surgical Robotic System into its Total Product Life ...

The program, part of Operation TrialBlazer, aims to speed early research and help the U.S. bring trials back from overseas.

On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...

This year, an unspecified number of drug developers will be eligible to take part in a pilot of the new US Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) program, ...

A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...

The IND pilot is part of the HHS's ongoing mission to onshore clinical trials.

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

THE WEIGHT IS OVER — Danish drugmaker Novo Nordisk won FDA approval Thursday for a higher dose of its weight-loss drug Wegovy — a decision FDA Commissioner Marty Makary touted on social media because ...

After one patient death prompted an FDA hold this spring, Newron Pharmaceuticals has now shared that a total of four ...