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Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland - February 6, 2023 Idorsia Ltd (SIX: IDIA) today announces the initial findings of REACT, a Phase 3 study which investigated the ....
Results published in the Journal of Neurosurgery show that clazosentan significantly reduced the combined incidence of vasospasm-related morbidity and all-cause mortality post-aSAH with no unexpected. | April 4, 2022 ....
Results published in the Journal of Neurosurgery show that clazosentan significantly reduced the combined incidence of vasospasm-related morbidity and all-cause mortality post-aSAH with no unexpected safety ....
Ad hoc announcement pursuant to Art. 53 LR Idorsia receives Japanese PMDA approval of PIVLAZ (clazosentan sodium) 150 mg Allschwil, Switzerland - January 20, 2022Idorsia Ltd (SIX: IDIA) and ....
Idorsia Pharmaceuticals Ltd: Idorsia submits NDA for clazosentan to Japanese PMDA Allschwil, Switzerland - March 1, 2021 Idorsia Ltd (SIX: IDIA) today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan, a fast-acting, selective endothelin A (ET A) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). The application is supported by replicated results from the Japanese registration program which consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality events in adult Japanese patients following aSAH. Patients were randomized to receive continuous infusion of either 10 mg/hr clazosentan or placebo for up to 15 days following the ons ....