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 ...
Yahoo Finance2d
Izotropic Completes Pre-Submission Meeting with FDA for Breast Cancer Screening Indication
is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025. The purpose of the meeting was to discuss ...
Yahoo Finance24d
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.
The Hill28d
FDA cancels meeting to choose flu vaccine strain
The Food and Drug Administration (FDA) abruptly canceled a vaccine advisory meeting where members were slated to discuss influenza vaccine strains. The meeting was scheduled for March 13.
manilatimes9d
XORTX Announces Update for Discussion with the FDA
The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application ...
Healio1d
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 ...
Medical Xpress29d
FDA cancels expert meeting on flu vaccines
Why was this meeting canceled? It's an important meeting. What's the plan for flu vaccines this year," Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education ...
CBS News28d
FDA cancels meeting to update next season's flu vaccines
Why was this meeting canceled? It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education ...
USA Today28d
Meeting of FDA vaccine advisers canceled, committee member says
The statement confirms a report by Reuters that the Vaccine and Related Biological Products Advisory Committee meeting, scheduled for March 13, has been canceled. An FDA spokesperson said the ...
ABC News28d
FDA cancels pivotal advisory meeting about next season's flu vaccine
"A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee on the influenza vaccine strains for the 2025-2026 influenza season in the northern ...
Detroit News28d
Trump administration cancels meeting of FDA vaccine advisers, risking flu-shot delay
The timing of the meeting is crucial because flu vaccine production is a lengthy process, with some doses still made using chicken eggs. Each year, FDA advisers meet to formally decide which flu ...
WCVB Channel 5 Boston28d
FDA cancels March meeting on flu vaccine composition without explanation
What’s the plan?” he said. The FDA confirmed the cancellation in a statement sent to CNN on Thursday. “A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products ...