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 SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR
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
Afrezza comes in single-use cartridges, delivered via a simple inhaler device. Users select the appropriate cartridge, load it, inhale the insulin, and remove the cartridge
Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option
The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa
FOP is a rare genetic disorder caused by mutations in the ALK2 kinase
SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers
The pharma company will donate more than seven tons of its active pharmaceutical ingredient (API) to bolster the American supply chain
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