In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location.

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.

Sarepta halts Elevidys shipments for non-ambulatory DMD patients after a second patient death in three months post gene therapy treatment.

The FDA has designated the viral vector rAAVrh74, which Sarepta Therapeutics, Inc. (NASDAQ:SRPT) uses in its gene therapy candidate SRP-9003 for limb-girdle muscular dystrophy type 2E/R4 (LGMD2E ...

With FDA platform technology designation for its viral vector, SRPT can fast-track other therapies using the same gene-delivery method.

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to ...

On June 20, the Food and Drug Administration (FDA) gave Sarepta Therapeutics (NASDAQ: SRPT) exactly what it wanted. The agency upgraded the status of its gene therapy for Duchenne muscular ...

FDA approves Sarepta's Elevidys for Duchenne muscular dystrophy patients with confirmed DMD gene mutation, aged 4+. Expanded label boosts revenue prospects for SRPT as payers and analysts show ...