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.

As with the drug's 2023 approval in castration-resistant tumors, it's not clear if it works comparably in all homologous ...

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

Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

Kura Oncology and Kyowa Kirin submitted data from the KOMET-001 trial, which the agency will review and decide whether to approve the drug by Nov. 30.