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 ...
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 ...
Morningstar7d
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 ...
Yahoo Finance29d
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 Bakersfield Californian13d
XORTX Announces Update for Discussion with the FDA
XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX \| TSXV: XRTX \| Frankfurt: ANU), a late stage clinical pha ...