Sarepta is the first company to publicly disclose that it's received the designation, for which the FDA had issued a draft guidance last year.

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.

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.

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

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.

Researchers are trying to better understand how co-mutations and PD-L1 expression impact response to single-agent KRAS G12C ...

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

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

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

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