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Minor Alert: Coffee Pods Recalled Over Ink Concerns, FDA Issues Lowest-Risk Warning
Your morning coffee ritual is usually a simple pleasure, but a recent recall of certain coffee pods might make you ...
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
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Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid Safety Concerns
The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
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.
Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...