The deaths prompted the FDA to ask Sarepta to stop shipping Elevidys for all patients, but the company refused to do so. Days later, it changed tack in order to maintain what it said was a “positive ...

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 ...

Arrowhead PharmaceuticalsARWR stock tumbled Thursday after Sarepta TherapeuticsSRPT liquefied its entire stake in the smaller biotech company.The beleaguered biotech giant sold more than 9.2 million ...

Sarepta stock has been in free fall since safety issues derailed Elevidys, a gene therapy analysts had expected to achieve ...

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

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 ...

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

Some oncologists and researchers have raised concerns about delays in the completion of confirmatory trials, but FDA now has new tools to push them ahead.