FDA extends review of Fortress Biotech's CUTX-101 drug
Fortress Biotech, Inc. (NASDAQ:FBIO), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has extended the target action date for the New Drug Application ...
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NDA and CDS 1 Exam 2025 Registration Closing Today: Check online application process, fee details, and correction window information
The article below provides detailed information about the NDA and CDS online application process, which includes application fees and other important information. Candidates who want to join the ...
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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. As previously reported ...
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Fortress, Cyprium announce FDA acceptance, priority review of NDA for CUTX-101
The NDA has been granted Priority Review and assigned a Prescription Drug User Fee Act target action date of June 30, 2025. TipRanks is the most comprehensive data set of sell side analysts and ...
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FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
The FDA has accepted for filing and priority review Sentynl Therapeutics’ CUTX-101 NDA for the treatment of Menkes disease.
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Fortress Biotech’s Subsidiary Cyprium Therapeutics Receives FDA Acceptance for CUTX-101 NDA Review
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for priority review, with a target action date set for June 30 ...
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 ...