There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the ...

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

Prasad was hired to lead the FDA’s vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy.

He has also slammed outgoing CBER director Dr. Peter Marks as “one of the most dangerous, pro-pharma regulators of the 21st century.” Shares of several biotech firms, including vaccine ...

The Vinay Prasad in the room Last year, hundreds of people poured in to see Peter Marks, the FDA’s head of biologics, speak at at ASGCT.

Now, of course, Marks has been fired by the Trump administration. And among the biggest questions facing the gene therapy field is what stance Vinay Prasad, the fiery hematologist and oft-pharma ...