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 ...

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.

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

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 ...

On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an ...

Shares of Gilead Sciences (NASDAQ:GILD) reached a session high on Wednesday after the U.S. Food and Drug Administration (FDA) ...