The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

In this week’s edition of InnovationRx, we look at Halle Berry’s menopause startup, Ambience Healthcare’s $243 million ...

Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the ...

Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task ...

A spokesperson for the Health Department has said that Vinay Prasad did not want to be a "distraction to the great work of the FDA in the Trump administration." ...

The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory ...

The approval to reduce proteinuria for those 12 and older with either of the two severe and rare kidney diseases came on the July 28 PDUFA date, a little more than four years after the company won ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

After our editorial, the agency relents to allow a Duchenne treatment.