If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
Alto met its enrollment goal with 83 patients across 13 US clinical sites
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
This achievement validates global demand and catapults Wanbury into high-growth acceleration
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
UK Prime Minister Keir Starmer praised the initiative, saying: “Unlocking opportunities for British businesses across the globe and delivering for working people back home is always the driving force behind my international engagements."
The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China
This marks the second indication for which gumokimab has gained NDA review acceptance
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