CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

The abrupt exit of the former CBER director, who quickly made his mark at the agency with several high-profile and ...

The moves come after the S&P 500 and the Nasdaq Composite hit new all-time and closing highs during Monday’s trading session.

-U.S. futures for the S&P 500 and Dow Jones Industrial Average rose 0.1% and Nasdaq futures gained 0.3%. Earnings will come today from Boeing, Spotify, United Health, Procter & Gamble, Visa and PayPal ...

Analysts are intrested in these 5 stocks: ( ($ETSY) ), ( ($CLS) ), ( ($BIIB) ), ( ($SRPT) ) and ( ($M) ). Here is a breakdown of their recent ...

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients ...

Wall Street traders left stocks at all-time highs while the dollar climbed the most since May, with a tariff deal between ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.