Replimune stock falls as FDA denies skin cancer drug approval and investors sue over alleged misstatements tied to the IGNYTE ...

The FDA's top regulator of cancer drugs interceded in a review of a Replimune skin cancer therapy, contributing to its ...

Replimune (REPL) stock plummets as report suggests FDA’s top regulator of cancer drugs intervened in rejecting its lead asset ...

Laura Loomer, the controversial far-right activist with a direct line to President Donald Trump, has taken credit for a slew ...

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

During his first term, Trump signed the “Right to Try” law, which allows terminally ill patients to seek treatments that haven’t been fully approved by the FDA, the AP reported.

Rare disease and gene therapy stocks, battered in recent months by clinical and commercial setbacks, will likely benefit from ...

Vinay Prasad, a professor who until earlier this year headed a cancer-drugs and health-policy lab at UC San Francisco, ...

The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...

Yet, under federal law, it is labeled "rare" because that definition is based on prevalence —a static snapshot of how many ...

Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam Roberts.

Vinay Prasad’s ouster as the Food and Drug Administration’s top vaccine and gene therapy regulator came after frustration ...