News

Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
BioSpace2h
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Fierce Pharma2h
FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
Arrowhead Pharmaceuticals Earns $100 Million Milestone from Sarepta Therapeutics
Detailed price information for Arrowhead Pharma (ARWR-Q) from The Globe and Mail including charting and trades.
Applied Clinical Trials Online3d
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
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 ...
Fierce Pharma4d
FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and ...
Sarepta Therapeutics stock tumbles on concern about FDA study requirements
According to Endpoints News, FDA officials stated that the Center for Biologics Evaluation and Research (CBER) review staff are "unanimous" that Elevidys should never return to market. The report ...
Zacks Investment Research on MSN6d
SRPT Slides on Voluntary US Elevidys Shipment Pause Amid Scrutiny
Shares of Sarepta Therapeutics SRPT are declining in the pre-market hours today after the announcement that it will ...
SRPT Down After Third Death in Muscular Dystrophy Gene Therapy Program
Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.
KFF Health News7d
Joint Commission Streamlines Standards, Cuts Requirements
Reducing redundancy and improving hospital compliance are among the goals. Other industry news is on health system purchases of physician practices, insurance claim denials, and more.
FDA Suspends Sarepta's Gene Therapy Trials After Deaths; But Company Declines ELEVIDYS Shipment Halt
The U.S. Food and Drug Administration announced that it has placed Sarepta Therapeutics' (SRPT) investigational gene therapy trials for limb-girdle muscular dystrophy on ...