PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

Such appeasement efforts proved insufficient to protect him from rival forces in the Republican Party, if not also in the ...

In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the ...

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...

George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...

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

Top FDA official Vinay Prasad recently drew outrage from conservatives, including Laura Loomer, who disagreed with his ...

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

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