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Complete response letters
REGENXBIO’s Hunter Rejection Hinged on Inadequate Controls, Surrogate Endpoint
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker levels or neurodevelopmental outcomes.
March 3, 2026
·
2 min read
·
Tristan Manalac
Press Releases
Sanaregen™ Vision Therapeutics Receives FDA Clearance for Clinical Trial to Treat Retinal Degeneration
March 3, 2026
·
2 min read
Press Releases
Esperion Therapeutics and Corstasis Therapeutics Announce Esperion’s Definitive Agreement to Acquire Corstasis, Expanding Its Cardiovascular Franchise with Enbumyst™ (bumetanide nasal spray)
March 3, 2026
·
11 min read
Press Releases
Asieris’ CEVIRA® Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions
March 3, 2026
·
9 min read
Press Releases
Kestra Medical Technologies to Report Third Quarter Fiscal 2026 Financial Results on March 17
March 3, 2026
·
1 min read
Press Releases
Tonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select Market
March 3, 2026
·
3 min read
Press Releases
Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01
March 3, 2026
·
7 min read
Press Releases
Quell Therapeutics Demonstrates Safety, Phenotypic Stability, Durability and Early Efficacy with Phenotype‑Locked™ CAR‑Tregs in LIBERATE Phase 1/2 Liver Transplant Study
March 3, 2026
·
5 min read
Press Releases
Quell Therapeutics Initiates CHILL Phase 1/2 Trial of Novel QEL-005 CAR-Treg Therapy in Refractory Rheumatoid Arthritis and Systemic Sclerosis Following UK CTA Approval
March 3, 2026
·
5 min read
Press Releases
SHERPA research consortium initiates seven clinical studies to validate AI-based assistive technologies for minimally invasive brain and cancer treatments
March 3, 2026
·
8 min read
1 of 87,328
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