The last time I spoke about Disc Medicine (IRON) it was with respect to a Seeking Alpha article entitled "Disc Medicine: Rare Disease Biotech With Enormous Potential". With respect to this article I ...
James V. Caruso, President and CEO, stated that Cellectar has made "significant strides across our development pipeline, regulatory strategy, corporate development initiatives and fundraising efforts, ...
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Achieve Life Sciences targets NDA submission for cytisinicline in June 2025 as open label study hits key milestones
CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...
Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review ...
Cytokinetics, Incorporated announced that the FDA has extended the action date for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), to December 26, 2025. The extension is due ...
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