… New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) … FDA compliance, allowing us to resubmit the OLC NDA … manufacturing vendor in resolving FDA-cited deficiencies and … Act target guidelines for NDA resubmissions include acknowledgment …

… US Food and Drug Administration (FDA) has granted Breakthrough Therapy … of positive interactions with the FDA, that, together with this … the filing of the ulixacaltamide NDA, which we expect in … expand treatment modalities.1 The FDA decision was supported by …

… after the FDA accepted Axsome Therapeutics’ resubmission of its new drug application (NDA) in … JANUARY 30, 2025 — The FDA approved suzetrigine (Vertex Pharmaceuticals), an … its original submission, the FDA approved Supernus Pharmaceuticals’ investigational …

… . Food and Drug Administration (FDA) granted Breakthrough Therapy Designation … of positive interactions with the FDA, that, together with … completed its pre-NDA meeting with the FDA, including the receipt … to submit the ulixacaltamide NDA in early 2026. PRAX …

… ahead of a pivotal FDA decision on tradipitant for … gastroparesis but is now under FDA review with labeling discussions … a year after the FDA rejected its application in … Letter (CRL) to the new drug application (NDA) for tradipitant for treating symptoms …

… Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation … of positive interactions with the FDA, that, together with … of its pre-NDA meeting with the FDA, including the receipt … to submit the ulixacaltamide NDA in early 2026. About …

… is reduced following positive pre-NDA FDA feedback and JAMA recognition, with … NDA submission expected late 2025 or …

… signaling plans to submit a New Drug Application for lorundrostat by early 2026 …

… turn, plans to submit a New Drug Application for ulixacaltamide in early 2026 …

… irbesartan. The FDA accepted Travere’s supplemental New Drug Application for traditional … FDA accepted the New Drug Application on June 16, 2025, following positive pre-NDA … cholangitis (PBC). The FDA accepted the New Drug Application in June 2025, …