News

Stocktwits on MSN6h
Replimune Stock Catches Retail Fire As Analyst Says FDA Shakeup Removes 'Major Obstacle' For Skin Cancer Drug's Potential Approval
Retail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...
TipRanks on MSN11h
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 ...
BioSpace14h
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 ...
Fierce Healthcare15h
Susan Monarez confirmed as CDC director
Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...
Healio15h
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 ...
Senate confirms CDC director as top FDA official resigns under political pressure
In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...
STAT16h
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 ...
The New York Sun17h
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the ...
BioSpace17h
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 ...
Just The News17h
FDA official resigns after pressure from White House, conservative criticism: reports
Dr. Vinay Prasad faced criticisms from disease advocates and conservatives over his decision to pause a muscular dystrophy ...
Sarepta, Replimmune, Capricor rise as FDA’s biologics head departs
Sarepta (NASDAQ:SRPT) stock, Replimune (NASDAQ:REPL) stock and Capricor (CAPR) stock surge as FDA's biologics head exits abruptly. Read more here.
Fierce Pharma20h
Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy
Vinay Prasad, M.D., has left the FDA less than three months into the role as director of the Center for Biologics Evaluation ...