Connect Biopharma Announces Positive Type C Meeting with the FDA for Rademikibart
FDA aligned on plan to initiate parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or COPD experiencing an ...
Teleflex Receives FDA 510(k) Clearance of the AC3 Range™ Intra-Aortic Balloon Pump (IABP)
CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.
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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 ...
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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.
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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 Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | ...
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FDA chief nominee Makary pledges to 'review' cancellation of vaccine panel meeting
Days after the U.S. FDA cancelled an annual meeting to discuss the makeup of the following season's flu vaccine, FDA Commissioner nominee Marty Makary pledged to review that decision if he is ...
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After canceling meeting of independent advisers, FDA issues 2025-26 flu vaccine recommendations
In order for flu vaccines to be sold in the US, they must contain strains that are officially selected by the FDA. That decision typically comes after a meeting of the World Health Organization ...
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Senator Murray among those criticizing canceling of FDA flu shot meeting
In a letter sent on Friday to Dr. Marty Makary, President Trump's nominee for FDA Commissioner, the senators criticized the cancellation, pushing the importance of the annual meeting. "The cancell ...