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Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
But uncertainty remains around the FDA's decision-making and whether patient demand for Elevidys will remain, the analysts said. The company voluntarily paused Elevidys shipments for ambulatory patients last week after previously rejecting the FDA's request that it do so.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
The pharma company said it would lay off a third of its workforce and add a black-box warning to its controversial gene ...
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Prasad’s FDA exit may accelerate cell and gene therapy approvalsVinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...
On a conference call, CEO Doug Ingram said the decision to cut 36% of the company's staff and halt several drug programs was ...
Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...
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Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
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