News

Vor Bio Appoints Seasoned Biotech Executive Dallan Murray as Chief Commercial Officer
Experienced commercial leader to shape launch strategy and global market readiness for telitacicept and future pipeline ...
BioSpace9h
‘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 ...
Fierce Pharma3d
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 ...
PTC Therapeutics: Uncertainty Abounds Ahead Of Q2 Earnings - I'm Upgrading To 'Hold'
PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...
FDA vaccine chief steps down after controversial tenure
The U.S. Food and Drug Administration's (FDA) top vaccine official is stepping down after just three months in a role that ...
The American Journal of Managed Care4d
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 ...
Fierce Pharma4d
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 ...
Andover Townsman4d
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 ...
BioWorld4d
In Broadway trial, a hopeful tune for Alzheimer’s prevention
At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...
Public Broadcasting Service (PBS)4d
Controversial FDA vaccine chief departs agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...
BioSpace4d
New CDER Head Tidmarsh Will Sub In At Biologics Group After Prasad’s Exit
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...