You are here: Industry Insights > Astellas

News List

Japan's Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin NDA americanpharmaceuticalreview
May 17, 2021
Astellas Pharma Inc. announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's New Drug Application (NDA), which was submitted in March.
Astellas’ Xtandi bags additional MHRA approval in prostate cancer pharmatimes
May 13, 2021
Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
EC approves Xtandi™ for third prostate cancer indication europeanpharmaceuticalreview
May 07, 2021
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer americanpharmaceuticalreview
April 20, 2021
Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration (FDA) filed two supplemental Biologics License Application (sBLA) submissions for PADCEV® (enfortumab vedotin-ejfv) for review as part of the ...
EMA accepts Astellas/Seagen’s enfortumab vedotin for review pharmatimes
March 29, 2021
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Astellas and Seagen’s enfortumab vedotin.
Astellas, Seagen Submit sBLAs for PADCEV for Urothelial Cancer americanpharmaceuticalreview
February 24, 2021
Astellas Pharma and Seagen announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV® (enfortumab vedotin-ejfv).
Astellas Expands Top Management americanpharmaceuticalreview
February 19, 2021
Astellas announced the expansion of its top management to include two new positions.
Astellas, Seagen Announce PADCEV Trial Results for Urothelial Cancer americanpharmaceuticalreview
February 18, 2021
Astellas Pharma and Seagen announced primary results from the phase 3 EV-301 trial comparing PADCEV® (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with ...
United Immunity and Xyphos, an Astellas Company, to Collaborate on Next Generation Nano-Immunotherapies for Cancer Treatment prnasia
January 15, 2021
United Immunity, Co., Ltd. has entered into a joint research agreement as of December 2020 with Xyphos Biosciences, Inc., (California, US), a subsidiary of Astellas Pharma Inc. (Tokyo, Japan).
Astellas Reports XOSPATA, Azacitidine Combination Did Not Meet Endpoint americanpharmaceuticalreview
December 23, 2020
Astellas Pharma announced that a Phase 3 trial of XOSPATA® (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction ...

Previous page 1 2 3 4 5 6 7 8 9 10 11 Next page