Nation
World
Politics
Sports
Business
Entertainment
Life
Tech
Science
Opinion
Crime
Health
Oddities

FDA advisers recommend accelerated approval of a Sarepta gene therapy

Por: The Boston Globe Business May 13, 2023

thumbnail

An panel of advisers Friday recommended that the Food and Drug Administration speed up approving a Duchenne muscular dystrophy treatment developed by Cambridge biotech Sarepta Therapeutics, despite questions about its clinical benefit and safety.By an 8 to 6 vote, the FDA advisers endorsed accelerated approval for the experimental gene therapy, called SRP-9001. The vote followed a daylong hearing, convened virtually, marked by sharp debate over... + full article



Similar News

FDA delays decision on Sarepta’s controversial gene therapy for muscular dystrophy

The Boston Globe USA Business May 24, 2023

thumbnailThe Food and Drug Administration is delaying by one month its long-awaited decision on whether to approve a gene therapy for a deadly inherited muscle-wasting disease that afflicts more than 10,000 boys and young men nationwide, according to the Cambridge biotech that developed... + más

FDA advisers recommend accelerated approval of a Sarepta gene therapy | The Boston Globe

First gene therapy for deadly form of muscular dystrophy gets FDA approval for young kids | ABC News


Sarepta Therapeutics Updates Of BLA For Sarepta's Duchenne Muscular Dystrophy Drug Candidate

RTTNews USA Health May 24, 2023

thumbnailSarepta Therapeutics, Inc. () on Wednesday provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who... + más

FDA advisers recommend accelerated approval of a Sarepta gene therapy | The Boston Globe

Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy | RTTNews


Under pressure from patients, FDA faces tough choices on experimental gene therapy

The Boston Globe USA Business May 23, 2023

thumbnailRegulators are to decide within days whether to clear a Cambridge biotech’s gene therapy for a deadly muscle-wasting disease that afflicts more than 10,000 boys and young men nationwide, even though questions remain about whether the treatment is safe and effective.The... + más

Gene therapy has made some recent progress—is it enough? | Ars Technica

FDA advisers recommend accelerated approval of a Sarepta gene therapy | The Boston Globe


Gene therapy has made some recent progress—is it enough?

Ars Technica USA Science January 05, 2023

thumbnailNavigate Filter by topic Settings Front page layout Site theme - Jan 5, 2023 12:45 pm UTC MARK GARLICK/SCIENCE PHOTO LIBRARY Share this story Gene therapy has had a long and bumpy history. Although researchers have made some notable and Despite these issues, experts say there... + más

Opinion | The New York Times

First participant in test of custom gene editing therapy dies | The Boston Globe


Opinion

The New York Times USA Opinion December 09, 2022

thumbnailThe parents of a 2-year-old girl write that their daughter “could die within the next year” because a genetic mutation is causing her heart to fail.“Time is quickly running out for me,” writes a man in his mid-30s whose DNA harbors a genetic mistake certain to destroy... + más

Justice Alito accused of being SCOTUS leaker after new report: Disgrace | Newsweek

Why would Mac Jones get a second opinion on his injury, and how common is that? | The Boston Globe


FDA approves most expensive drug ever, $3.5 million-per-dose gene therapy for hemophilia B

CBS News USA Health November 23, 2022

thumbnailWashington — U.S. health regulators on Tuesday approved the first gene therapy for hemophilia, a $3.5 million one-time treatment for the blood-clotting disorder. The Food and Drug Administration cleared Hemgenix, an IV treatment for adults with hemophilia B, the less common... + más

$3.5M gene therapy for hemophilia gets FDA approval | ABC News

$3.5M gene therapy for hemophilia gets FDA approval | WPLG Local 10


Sarepta Submits BLA For SRP-9001 To Treat Ambulant Patients With Duchenne Muscular Dystrophy

RTTNews USA Health September 29, 2022

thumbnailGenetic medicine maker Sarepta Therapeutics, Inc. () announced Thursday that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients... + más

Diageo Debuts Its 2022 Special Releases Collection | Forbes

Parents of son diagnosed with Duchenne muscular dystrophy are hopeful cure will be found soon | ABC7



About iurex | Privacy Policy | Disclaimer |