With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...

Pounding away on a prison typewriter, Chad Scott seemed worlds apart from President Donald Trump. But when the disgraced ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

A new cancer drug candidate has demonstrated the ability to block tumor growth without triggering a common and debilitating ...

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.

World leaders are dismantling global health programs and cutting back foreign aid. Will an extraordinary new medicine be able ...

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...

The U.S. Food and Drug Administration (FDA) has unveiled the Commissioner’s National Priority Voucher (CNPV) program, aiming ...

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 ...