News

Why Trump ordered ouster of FDA official
The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...
The American Journal of Managed Care34m
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 ...
BioSpace19h
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 ...
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), ...
Healio20h
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 ...
PharmExec20h
IGNYTE Trial Investigators Press FDA to Reconsider Replimune CRL Amid Promising Melanoma Data, Leadership Shakeup
Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...
Top FDA Official’s Surprise Departure Means More Uncertainty for Biotech
A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...
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 ...