Astellas Pharma US, Inc.
737 articles about Astellas Pharma US, Inc.
Astellas' VEOZAH™ (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12.
Astellas Pharma Inc. and Iveric bio, Inc. announced that on April 29, 2023, the Companies have entered into a definitive agreement under which Astellas through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding shares of Iveric Bio for US$40.00 per share in cash for a total equity value of approximately US$5.9 billion.
Japanese biopharma scoops up Iveric’s investigational drug for age-related blindness disease. The drug, which trails Apellis’ Syfovre, is awaiting FDA approval with a decision expected by August.
XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide
Astellas Pharma Inc. and Pfizer Inc. announced that XTANDI® plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide, as assessed by the primary endpoint of metastasis-free survival, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.
Twist Bioscience Enters into Third Collaboration with Astellas to Support Antibody Discovery for Immunotherapies
Twist Bioscience Corporation today announced a collaboration with Astellas Pharma Inc.
Results from Astellas' Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet
Astellas Pharma Inc. announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin 18.2 targeted monoclonal antibody, plus mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.
FDA Grants Accelerated Approval for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer
Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration has granted PADCEV® with KEYTRUDA® accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
Astellas and Roche Diabetes Care Japan ink partnership agreement to develop and commercialize integrated diabetes self-management solution with BlueStar®
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that it has entered into an agreement ("the Agreement") with Roche Diabetes Care Japan Co., Ltd. (Country Manager: Noriko Hattori, "Roche Diabetes Care Japan") for the development and commercialization of Roche Diabetes Care's world-renowned Accu-Chek® Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar.
Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced The Lancet published detailed results from the pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) versus placebo plus ADT.
Astellas and Seagen Announce China's National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer
Astellas Pharma Inc. and Seagen Inc. announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted the Biologics License Application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Astellas Pharma Inc. and the Blood and Marrow Transplant Clinical Trials Network announced topline results from the Phase 3 MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation for patients with FMS-like tyrosine kinase 3 -internal tandem duplication mutated acute myeloid leukemia.
After overcoming a clinical hold, Astellas presented preliminary safety and efficacy data from the Phase I/II FORTIS trial of AT845 in late-onset Pompe disease at the 19th Annual WORLDSymposium 2023.
Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced an update on preliminary safety and efficacy data from its ongoing FORTIS Phase1/2 clinical trial evaluating the safety, tolerability and exploratory efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD).
Astellas Pharma Inc. announced the U.S. Food and Drug Administration notified the company that it is extending the original priority review Prescription Drug User Fee Act goal date for fezolinetant, an investigational agent for the treatment of moderate to severe vasomotor symptoms due to menopause.
Generian Pharmaceuticals, Inc. announced that it has achieved the first research milestones for two programs in development under its collaboration agreement with Mitobridge, Inc.
Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.