Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

On September 29, 2025, the U.S. Food and Drug Administration (FDA) announced the expansion of its Early Alert program to include all medical devices. This expansion builds on a pilot program that ...

More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...

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 ...

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

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 ...

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 ...