Drug Approval | March 12, 2026
FDA nod to first treatment for rare genetic brain disorder
The approval comes after a systematic review of published literature
The approval comes after a systematic review of published literature
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
This marks the second indication for which gumokimab has gained NDA review acceptance
Vanda strongly disputes the FDA’s reasoning
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
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