As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt ...

A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.

British biopharmaceutical company GlaxoSmithKline will lay off 150 employees in its Cambridge operations by the end of March ...

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.

Sarepta stock (SRPT) declined 5% in premarket trade, after falling 36% on Friday, when it disclosed a patient death due to liver failure.

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

Although the center didn’t lose staff in the reduction-in-force, it lost probationary employees in February ... Reuters’ Bhanvi Satija reports that Sarepta Therapeutics won’t comply with the FDA’s ...

Reducing redundancy and improving hospital compliance are among the goals. Other industry news is on health system purchases of physician practices, insurance claim denials, and more.

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...