Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

The initiative, referred to as the Commissioner’s National Priority Voucher program, allows drug developers to participate in a novel FDA priority program. The program significantly shortens the FDA ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

FDA approval of VYKAT XR for hyperphagia in Prader-Willi Syndrome marks a major milestone for Soleno Therapeutics.

The Supreme Court ruled on Friday that a challenge by retailers to the Food and Drug Administration’s denial of an ...

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

The FDA announced a new national priority voucher plan that aims to cut drug review times, while Headspace launches direct-to ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...