The company also confirmed that ABS-1230 has been accepted into the U.S. Food and Drug Administration’s Rare Disease Evidence Principles (RDEP) process
The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
Stroke is the second-leading cause of death and the third-leading cause of disability worldwide
The trials -- ELOWEN-1 and ELOWEN-2 -- are designed to evaluate the drug in people living with lupus who experience active skin manifestations
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
The deals, tied to cases in the US District Court for the District of Delaware, effectively extend US patent protection for VYNDAMAX until June 1, 2031
After Phase 3 results show major hair regrowth gains
The approval was driven by data from the Phase III TULIP-SC trial
The study evaluated oral semaglutide in young patients with type 2 diabetes and found it delivered a superior reduction in HbA1c
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