Trump administration health officials assured drugmakers and researchers at a roundtable hosted by the FDA that they want to ...

The study adds to growing evidence that digital tools can maximize genetic counselors' limited time without patient harm.

Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

Vepdegestrant showed a benefit for patients with ER-positive, HER2-negative, ESR1-mutated breast cancer who had previously received endocrine-based therapy.