The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

And offering a fast-track to approve drugs the Trump administration views as a priority. Welcome to the new Food and Drug ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...

Nicole Verdun, a highly respected individual in the cell and gene therapy space, was placed on administrative leave this week ...

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on ...

According to an internal email, the agency may be in for more consolidation in areas including human resources, ...

As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.