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

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

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

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...

The Food and Drug Administration commissioner repeatedly said patients should rely on guidance from their doctors.

FDA Commissioner Marty Makary’s pledge to reexamine the safety of medication abortion isn’t just pointless — it’s dangerous.

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

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

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