Exclusive - US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...
Becker's Hospital Review

FDA delays 2 drug reviews in priority voucher program

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.
JD Supra

New FDA Program Prioritizes Review of Certain ANDAs

On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
Yahoo

FDA names former pharmaceutical company executive to oversee US drug program

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 ...
BioPharma Dive

5 FDA decisions to watch in the first quarter of 2026

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...
JD Supra

Cell & gene therapy clinical trials, development promoted in three new FDA guidance documents - Trends in Cell, Tissue, and Gene Therapies

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...
MD&M East

FDA Expands Medical Device Recall Alert Program

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...
Columbus Dispatch

FDA-Authorized Expanded Access Programs Utilizing Jaguar Health’s Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with ...

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 ...