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Results For "Project-Orbis"

12 News Found

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
Drug Approval | June 12, 2023

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities


U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant