Keynote -564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Both these innovations are aimed at reducing the risk of relapse post CAR T cell therapy
PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
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