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 ...
Two months ago, when a federal appeals court rejected United Therapeutics’ attempt to revive an invalidated patent on its aging pulmonary arterial hypertension drug Tyvaso (treprostinil), it cleared ...
Court dismisses United Therapeutics' claim against Liquidia's YUTREPIA NDA, allowing potential final approval post-regulatory exclusivity expiration in 2025. The U.S. District Court dismissed a ...
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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 ...
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, ...
Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...
Unicycive Therapeutics, Inc. ("Unicycive" or the "Company") (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients ...
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