资讯

Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Managed Healthcare Executive17 小时
Sarepta to Pause Shipments of the Gene Therapy Elevidys
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...
In a reversal, Sarepta says it will pause shipments of gene therapy linked to deaths
By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
Becker's Hospital Review13 小时
Sarepta reverses course, halts gene therapy shipments following FDA request
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 ...
Sarepta to pause Elevidys gene therapy shipments in US
Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...
Fierce Pharma16 小时
Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys
A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...
Precision Medicine Online14 小时
Sarepta to Now Voluntarily Pause Shipments of Elevidys Duchenne Gene Therapy
The FDA had made the request Friday, which Sarepta initially rebuffed, following the death of a third patient treated with one of the firm's gene therapies.
Investing28 天
Sarepta Therapeutics’ SWOT analysis: gene therapy leader faces safety ...
Sarepta faces competition in the gene therapy space from companies like Avidity Biosciences and Dyne Therapeutics, which are developing their own approaches to treating muscular dystrophies.
AOL29 天
FDA investigates patient deaths after treatment with Sarepta's gene therapy
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. Both boys were non-ambulatory ...
Yahoo Finance28 天
Sarepta Viral Vector Gets FDA Platform Technology Designation
The rAAVrh74 viral vector is a key component in several of Sarepta’s gene therapy programs, including Elevidys, an already FDA-approved gene therapy for Duchenne muscular dystrophy.