Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% Friday, halting the momentum the stock generated just a day earlier after ...

Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...

Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...

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Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

Organon said on Wednesday it will the stop development of an experimental treatment it acquired through its purchase of Forendo Pharma, after the drug failed to reduce pelvic pain in women with ...

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action ...

Sarepta Therapeutics (NasdaqGS:SRPT) recently provided updates that may have influenced its stock performance. The announcement of a safety update for ELEVIDYS, concerning severe side effects and ...

Sarepta Therapeutics (NasdaqGS:SRPT) recently provided updates that may have influenced its stock performance. The announcement of a safety update for ELEVIDYS, concerning severe side effects and a ...

Sarepta then announced the second patient's death earlier this month and voluntarily paused treating non-ambulatory DMD patients with Elevidys as a result. The firm said it is developing a new ...