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FDA
UniQure snags May Day decision date for Huntington’s gene therapy after arduous year
After a year of controversial regulatory reversals, the FDA has accepted uniQure’s application for ifezuntirgene inilparvovec for priority review, with a May 1 action date. If approved, the therapy—also called AMT-130—would be the first disease-modifying treatment for Huntington’s disease.
November 2, 2026
·
2 min read
·
Heather McKenzie
Press Releases
UroGen Announces First Patient Dosed in Phase 1 Trial of UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
November 2, 2026
·
6 min read
Press Releases
TCT 2026 Clinical Data Reveals 84% Reporting Gap in Aortic Valve Calcification, Highlighting the Potential of Nanox.AI’s AVC Solution
November 2, 2026
·
9 min read
Press Releases
Caldera Therapeutics Appoints Michelle Doig as Chief Financial Officer and Lee Giguere as Chief Legal Officer
November 2, 2026
·
10 min read
Press Releases
Graviton BioScience and CinRx Pharma Form CinRock Pharma to Advance ROCK2-Targeted Therapies for Cardiovascular Disease
November 2, 2026
·
5 min read
Press Releases
Merck to Present New Data from Its Broad Oral HIV Portfolio and Pipeline at HIV Glasgow 2026
November 2, 2026
·
17 min read
Press Releases
Agenus Announces Nature Medicine Publication of Multicenter UNICORN Phase 2 Trial Demonstrating Deep Responses with Neoadjuvant BOT+BAL in Resectable Colon Cancer
November 2, 2026
·
10 min read
Press Releases
Atom Therapeutics to Present Phase 2b/3 Data Showing Superior Efficacy of Lingdolinurad (ABP-671), Compared to Febuxostat, for Patients with Chronic Gout and Hyperuricemia at ACR Convergence 2026
November 2, 2026
·
4 min read
Press Releases
Bright Minds Biosciences Provides Update About Planned Study with BMB-101 in Developmental and Epileptic Encephalopathies
November 2, 2026
·
6 min read
Press Releases
CorMedix Therapeutics Provides Business Update, Reaffirms 2026 Total Revenue Guidance, and Reports Third Quarter Cash Position
November 2, 2026
·
5 min read
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