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

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

Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.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

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

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.

Within weeks of treating patients with CER-1236, the company hopes to start learning about its safety profile and gauge efficacy markers.

The partners further aim to raise awareness and increase early diagnosis of BAG3-associated dilated cardiomyopathy.

Only 6 percent of patients carried a concerning DPYD variant, but nearly two-thirds of them were later hospitalized after ...

A combination of BRAF and MEK inhibitors plus immunotherapy improved progression-free but not overall survival, compared to dual immune checkpoint blockade.

The Australian company is betting the radionuclide could be an option for patients with HER2-expressing solid tumors who can't tolerate other treatments.

The French company is designing a Phase IIb program to validate the biomarker, which could identify the 30 percent of patients likely to respond to the antibody.