News

Fierce Pharma48m
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 ...
The American Journal of Managed Care17m
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Amazon S3 on MSN19h
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 ...
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 ...
TipRanks on MSN15h
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
Gene Therapy Market Fueled By CRISPR Advances & Regulatory Momentum Datam Intelligence
Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...
STAT3m
Moderna announces layoffs, and Alnylam’s heart drug sees quick uptake
Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
US FDA's top vaccine official Vinay Prasad leaves agency after 3 months
The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...
GlobalData on MSN19h
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), has stepped down, with market analysts forecasting a boost to the cell and ...
BioSpace21h
Exit Stage Right: With Prasad Out, Analysts Hope for More Traditional Replacement
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...
STAT21h
STAT breaks down the confusing, heartbreaking Sarepta saga
In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...
Andover Townsman4h
493 employees laid off at biopharmaceutical company with operations in Andover
A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...