The Food and Drug Administration on Monday named George Tidmarsh, a longtime biotech executive who has a background in ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

A Massachusetts biotechnology company is laying off nearly 500 employees, more than a third of its total workforce, as it faces pushback from the U.S. Food and Drug Administration on one of its ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The layoffs followed a March announcement by Health Secretary Robert F. Kennedy Jr., who called for a major department overhaul.

An estimated 53 drugs would not enter the market in the next 30 years if the NIH is hit with a permanent 10% budget cut and the FDA experiences a nine-month drug review delay due to staffing cuts, the ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...