Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
Iberdomide has the potential to be the first approved CELMoD agent
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
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