REGENXBIO Inc. (NASDAQ:RGNX) is one of the biotech stocks to buy according to Wall Street analysts. On July 10, REGENXBIO announced the publication of preclinical results for its investigational gene ...

Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. WASHINGTON — The Food and Drug ...

The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla.

Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the Food and Drug Administration after a pressure campaign from far-right ...

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 ...

A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...

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

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

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

Vinay Prasad, FDA's top vaccine official, has resigned after three months amid criticism and controversy, especially concerning the FDA's handling of a gene therapy for Duchenne muscular dystrophy.

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