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The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take ...
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the ...
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the most undervalued stocks to buy and hold for 3 years. On July 22, BMO ...
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