The FDA has fast-tracked six therapies since December 2025 through its priority review and National Priority Voucher programs, including the first approval issued under the agency’s new pilot pathway.

Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that ...

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON (AP) — The Food and ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — A new program ...

Florida launched a program to import prescription drugs from Canada to save money for residents and state taxpayers.

Lawmakers are pressing the FDA for answers about its Commissioner’s National Priority Voucher program, voicing concerns over potential corruption, safety risks and transparency issues. In a Nov. 20 ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company’s novel ...