Vanda Pharmaceuticals issues letter to FDA on faulty gastroparesis NDA review
Vanda Pharmaceuticals (VNDA) issued a letter to FDA Commissioner highlighting what the company considers a faulty gastroparesis NDA review.
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Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
JD(U) in or out of NDA in Manipur? Confusion prevails
State chief writes to the Governor to “further reiterate” the party’s stand even as central leadership and lone legislator’s ...
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Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. Vanda Logo (PRNewsfoto/Vanda ...
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JD(U) Withdraws Support To NDA In Manipur? Nitish Kumar's Party Clarifies Amid Uproar
While the development poses no threat to the NDA alliance at the centre or its government in Manipur, but the move is a ...
Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
Today, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's NDA for tradipitant for the treatment of gastroparesis. The full ...