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 ...
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 ...
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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