Healio4d
Senate confirms Trump's picks to lead NIH and FDA
The Senate voted Tuesday to confirm the heads of two major federal health agencies. Jay Bhattacharya, MD, PhD, will become ...
Xortx Therapeutics to provide Type B meeting package to FDA during next week
XORTX Therapeutics (XRTX) provided an update regarding communications with the US Food and Drug Administration. At the request of the FDA a ...
Genelux announces alignment with FDA of approval pathway for Olvi-Vec
Corporation announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration, FDA, ...
XORTX Announces Update for Discussion with the FDA
Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- XORTX ...
Morningstar5d
Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
The purpose of the FDA meeting was to discuss the FDA’s expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec. In response to a question ...
MedPage Today25d
Makary Sails Through Nomination Hearing for FDA Commissioner
So how will you ensure that advisory committees remain objective ... to stand behind the FDA's long-standing determination" that the drug was safe. "But after our meeting -- I don't know if ...
Yahoo Finance27d
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission
The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned sNDA submission including the clinical and nonclinical requirements.