The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...

Sarepta Therapeutics' recent setbacks and restructuring have pressured Arrowhead's share price. Read why I am reiterating my bullish rating on ARWR stock.

Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...

The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...

The FDA issued its highest-level risk warning for a recent voluntary recall of hundreds of boxes of organic blueberries manufactured in Georgia by Alma Pak International over possible listeria ...

Alma Pak International has issued a voluntary recall of bulk organic blueberries, affecting 400 boxes, each containing 30 pounds of the fruit.

Alma Pak International LLC issued a voluntary recall for 400 boxes of its organic blueberries on June 9 due to possible listeria contamination.