Business Insider9h
PharmaTher Announces Post Complete Response Letter Clarification Meeting Request Granted from the FDA for Ketamine Abbreviated New Drug Application
On November 12, 2024, the FDA granted the Meeting scheduled for November 29, 2024. Due to the U.S. Thanksgiving Holiday and scheduling conflicts of attendees from its CDMO partner, the Company has ...
Business Insider1d
Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review ... VII protein which is ...
Business Wire1d
Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a ...
Investing26d
BTIG sustains Buy rating on HUMA shares amid FDA form 483
On Friday, BTIG reaffirmed its Buy rating and $10.00 stock price target for Humacyte (NASDAQ:HUMA) following the release of a Form 483 from the FDA. The form, which details findings from facility ...
Reuters27d
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
The company said it was not yet established that the vaccine had caused the safety event and it was working with the FDA to resolve the pause. "Our goal is to successfully resolve this matter and ...
Business Wire29d
Formlabs Announces Form 4L, New Blazing Fast, Large-Format SLA Printer, and Introduces Developer Platform
New Developer Platform delivers more flexibility and control to unlock new workflows, applications, and material options. New bulk material pricing brings prices as low as $35 per liter for SLA ...