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Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.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

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

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

Researchers at ASCO's annual meeting also discussed the importance of repeat biopsies to assess HER2 status after first-line ...

Researchers at ASCO provided a look at DB-1310 and iza-bren in genomically altered NSCLC, amid an overall survival miss for ...

A combination of Enhertu and Perjeta nearly doubled progression-free survival compared to standard therapy in data presented ...

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

Gilead has already announced intentions to bring the data, which demonstrated a 35 percent reduction in risk of progression ...

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