News

FDA Chief Says He Wants Gene Therapy Head Prasad to Return
US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head ...
FDA’s Reversal on Gene Therapy Helps My Son
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma5d
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
Amazon S3 on MSN6d
The story of Sarepta's Duchenne gene therapy
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
Sarepta to Report Q2 Earnings: What's in Store for the Stock?
SRPT's Q2 report, set to arrive Aug. 6, is likely to have Elevidys updates, restructuring plans and sales outlook in sharp investor focus.
BioSpace1d
Cracking the Commercial Code for Cell and Gene Therapies
From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...
What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?
Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.
Fierce Pharma6d
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
BioSpace2d
‘Unprecedented’ FDA Leaks Sow Confusion For Patients, Sarepta and Capricor
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...
GlobalData on MSN6d
Prasad’s FDA exit may accelerate cell and gene therapy approvals
Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...
Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy
Dr Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene therapy and pressure from the White House. He plans to return to California to ...
Rheumatology Advisor1d
Elevidys Use for Ambulatory DMD Patients May Resume, Says FDA
The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.