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The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

Still others wrote letters to the Food and Drug Administration directly. They demanded the FDA restore access to the drug ...

AbbVie unveiled a $195 million investment to expand active pharmaceutical ingredient manufacturing in the U.S. Bloomberg reported that BlinkRx, a company that has Donald Trump Jr. on its board, just ...

Liquidating its stake in Arrowhead helps Sarepta cover a milestone payment and secure what one analyst described as ...

The stock has been in free fall since safety issues derailed a gene therapy analysts had expected to achieve blockbuster ...

Sarepta will sell back $50 million worth of shares to cover part of a $100 million milestone payment and its remaining shares worth $174 million.

Sarepta Therapeutics is selling off Arrowhead Pharmaceuticals’ shares to stretch its cash runway, while also inking a share ...

Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

This episode of Pharma Pulse covers Vinay Prasad’s return to lead the FDA’s biologics center after a brief resignation, new ...

WASHINGTON, DC – Dr. Vinay Prasad has been reinstated to a senior position at the Food and Drug Administration, according to ...