Biotech | January 12, 2026
Complement Therapeutics’ gene therapy gains FDA fast-track for vision loss treatment
CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
Vanda strongly disputes the FDA’s reasoning
The deal brings Labcorp’s U.S. portfolio—including biocompatibility, microbiological, and analytical testing, as well as preclinical research—under NAMSA’s roof
Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories
The mPTP plays a key role in mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative diseases
The partnership aims to develop a first-in-class broad-spectrum antifungal to combat life-threatening invasive infections
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
Ventyx's clinical pipeline includes multiple small molecules with potential for oral therapies addressing chronic inflammation
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
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