News | January 23, 2026
Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator
This marks the second indication for which gumokimab has gained NDA review acceptance
This marks the second indication for which gumokimab has gained NDA review acceptance
Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike
The partnership will launch a Phase 1b cohort within Boehringer’s ongoing Beamion-BCGC1 trial
CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
The guidelines also support reusing tenofovir and abacavir in later regimens for improved outcomes, cost savings, and programmatic efficiency
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
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