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TOKYO and NEW YORK, July 13, 2018 –Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action bro...
-Enrollment of EV-201 Pivotal Trial Cohort Designed to Support Potential Expedited Registration Pathway in the U.S. Completed-
-First Patient Dosed in Phase 3 Global Confirmatory Trial-
BOTHELL, Wash., and TOKYO, July 9, 2018 – Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced completion of enrollment f...
TOKYO, July 2, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it has received an approval for the marketing application of Dafclir® Tablets (generic name: fidaxomicin) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile (CD)2) in Japan...
Results show enzalutamide plus androgen deprivation therapy significantly reduced the risk of developing metastases or death by 71 percent compared to placebo plus androgen deprivation therapy
TOKYO, June 29, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that results from the pivotal Phase 3 PROSPER trial, which evaluated enzalutamid...