According to Endpoints News, FDA officials stated that the Center for Biologics Evaluation and Research (CBER) review staff are "unanimous" that Elevidys should never return to market. The report ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause ...

Federal criminal and civil investigations are underway against UnitedHealth Group’s market-leading Medicare business. The ...