Drug Approval | December 27, 2025
EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation
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
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Adverse events were consistent with valbenazine’s established safety profile
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials
At one year, the drug met its primary and all key secondary endpoints, delivering significantly better weight maintenance than placebo
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