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Pasteurization is the process of heating a food product for a certain amount of time to destroy bacteria and viruses present, according to the Centers for Disease Control and Prevention (CDC). Dairy ...
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 Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.
Your morning coffee ritual is usually a simple pleasure, but a recent recall of certain coffee pods might make you ...
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 ...
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...
The FDA just proposed 52 food regulation changes — but you probably haven’t noticed why. 遼拏 One dietitian says the real issue isn’t what’s changing: ...