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US Stock market today saw the Dow, S&P 500, and Nasdaq inch higher as Wall Street kicked off a packed week of Big Tech ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Shares of drugmaker Sarepta Therapeutics continued to sink Tuesday after the company said it would comply with a Food and ...
Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...
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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 FDA’s language in its Tuesday communication set the parameter for the investigation around treatment of non-ambulatory patients.
Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology Designation to the rAAVrh74 viral vector.
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
Today's biotech news features an FDA probe into the deaths tied to Sarepta's Duchenne drug, rejecting KalVista's drug application, etc.
The Food and Drug Administration is conducting an investigation following the deaths of two patients treated with Sarepta's gene therapy for Duchenne muscular dystrophy.
In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment.
Sarepta Therapeutics Inc. (NASDAQ: SRPT) is one of the best mid cap growth stocks to invest in now. Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology ...
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