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193,531 Results for "fortress biotech".
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Complete response letters
Fortress, Sentynl Fail To Secure FDA Nod in Rare Pediatric Disease
As with recent rejections for Biogen and Scholar Rock, manufacturing issues stymied a regulatory bid from Fortress Biotech and Sentynl Therapeutics. Fortress said the FDA did not flag problems with the drug’s safety or efficacy.
October 1, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission
December 16, 2025
·
7 min read
Press Releases
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Approval of ZYCUBO® (copper histidinate), the First and Only Approved Treatment for Menkes Disease in the United States
January 13, 2026
·
13 min read
Press Releases
Fortress Biotech Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
November 17, 2025
·
16 min read
Press Releases
Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101
October 2, 2025
·
7 min read
Press Releases
Fortress Biotech and Subsidiary Urica Therapeutics Announce Crystalys Therapeutics’ $205 Million Series A Financing
October 2, 2025
·
6 min read
Approvals
Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
January 13, 2026
·
2 min read
·
Tristan Manalac
Press Releases
Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout
October 22, 2025
·
6 min read
Press Releases
Fortress Biotech to Present at the H.C. Wainwright 27th Annual Global Investment Conference
September 3, 2025
·
1 min read
Fortress Biotech Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
August 15, 2025
·
14 min read
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