The approval is based on overall response rates from the Phase II eNRGy study, which enrolled advanced, previously treated NRG1 fusion-positive patients.

CMS has negotiated outcomes-based agreements for sickle cell gene therapies with the two companies on behalf of participating state Medicaid programs.

NCI will include the multi-kinase inhibitor in the umbrella trial evaluating targeted therapy combinations in AML and MDS patients.

NEW YORK – Relay Therapeutics and Elevar Therapeutics on Wednesday announced an exclusive global licensing agreement for lirafugratinib (RLY-4008) in FGFR2-driven cancers.

Novartis licensed PTC's PTC518 Huntington's disease program and related molecules and will pay $1 billion upfront as well as other costs.

In recommending Kimmtrak, NICE factored in a new commercial agreement with the sponsor and changed its 2023 negative opinion.

A neurologist orders the wrong genetic test for a patient experiencing peripheral neuropathy and doesn't realize it even upon ...

In the study, the firm will enroll previously treated patients whose tumors are positive for FRα based on IHC testing.

The firm plans to put the proceeds toward further developing its cell therapy in CD33- or FLT3-expressing AML and for other R&D activities.

The trials are evaluating an individualized neoantigen vaccine with Keytruda as an adjuvant therapy for non-small cell lung cancer.

The agency is also evaluating if there's a need for further regulatory action based on reports of hematologic malignancies from clinical trials of the therapy.