News

Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
Precision Medicine Online1d
Sarepta Halts Duchenne Gene Therapy Sales Amid FDA Scrutiny, Raising Concerns Over Financial Future
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
BioPharma Dive10d
Vertex secures Alyftrek coverage in England; Merck starts Phase 3 trials of HIV drug
NHS England agreed to reimburse Vertex's newest cystic fibrosis medicine. Meanwhile, Merck advanced a once-monthly PrEP pill ...
BioSpace1mon
FDA Reviews Sarepta’s Elevidys After Second Patient Death
The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the aftermath of two patient deaths, though the regulator has not yet specified ...
Yahoo Finance1mon
Sarepta Viral Vector Gets FDA Platform Technology Designation
Earlier on June 4, Sarepta Therapeutics announced that the US FDA has granted Platform Technology Designation to the rAAVrh74 viral vector.
Yahoo Finance1mon
FDA Grants Platform Technology Tag to Sarepta's Gene Therapy Vector
With FDA platform technology designation for its viral vector, SRPT can fast-track other therapies using the same gene-delivery method.
Investing1mon
Sarepta gene therapy vector gets FDA platform designation
CAMBRIDGE, Mass. - Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced that its rAAVrh74 viral vector, used in the investigational gene therapy SRP-9003 for limb-girdle muscular dystrophy type 2E ...
MedCity News11mon
Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA ...
Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to ...
MedCity News1y
FDA Approves Sarepta Gene Therapy, But Only After Top FDA Official ...
FDA reviewers concluded the data for Sarepta Therapeutics’ Elevidys were insufficient to show efficacy in the rare muscle disorder Duchenne muscular dystrophy. Peter Marks, the agency’s top ...