资讯

Fierce Pharma12 小时
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 ...
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 Care1 天
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 ...
India Today on MSN1 天
What forced Vinay Prasad to exit top job at US FDA in just 3 months
Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...
Fierce Pharma1 天
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Andover Townsman1 天
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 ...
TipRanks on MSN2 天
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 ...
Public Broadcasting Service (PBS)2 天
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 ...
BioSpace2 天
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 ...
Healio2 天
Oncologist who served as FDA’s chief medical officer, top vaccine official departs agency
A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...
devdiscourse13 天
Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid ...
The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...