News

- Data from the Phase 3 EV-303 trial found that enfortumab vedotin plus pembrolizumab showed a 60% reduction in the risk of disease recurrence, progression or death, and a 50% reduction in the...

TOKYO, January 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference,...

- Pioneering cell therapy innovation through robotics and AI - - Among the first innovator pharmaceutical companies granted AMT designation - - Enabling early, priority engagement with FDA to...

PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients...

- Data reflect new insights and precision oncology advancements in portfolio and pipeline - - Cohort results from Phase 2 ILUSTRO study evaluating a zolbetuximab triplet combination regimen in...

- Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML - - Findings from the...

TOKYO, November 28, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) validated for review a Type...

- PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible...

TOKYO, October 30, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced revisions to its consolidated financial forecast for the fiscal year...

View Financial Results of Astellas for Q2 YTD/FY2025.

Extensive and growing evidence continues to reinforce fezolinetant as an effective treatment for moderate to severe VMS associated with menopause Preliminary analysis from OPTION-VMS observational...

Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by...

In GATHER2 open-label extension study, IZERVAY reduced GA growth 37-40.5% vs. projected sham, with earlier intervention resulting in greater protection of retinal tissue area Study results found...

First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer Unprecedented survival...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that VEOZAH™ (fezolinetant), its first-in-class, targeted, non-hormonal treatment for moderate to...

TOKYO, October 14, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Phase 2 GLEAM trial investigating zolbetuximab in combination...

Presentations include long-term GATHER2 open-label extension data, real-world treatment patterns on safety, and biomarker insights on geographic atrophy disease progression TOKYO, Oct. 8, 2025...

- New clinical data across ten accepted abstracts demonstrate significant progress across Astellas' innovative oncology programs - - Results from the EV-303 trial (also known as KEYNOTE-905) in...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the following changes to its Top Management structure, effective October 1, 2025. Nick Eshkenazi,...

TOKYO, Sep 19, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has...

NEW YORK AND TOKYO, August 12, 2025 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from...

- Supporting Korean Startups’ Drug Discovery Research and Global Expansion - - First Pharmaceutical Company from Japan to Actively Support the Operation of the Program - TOKYO, July 17, 2025 –...

TOKYO, July 10, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the sales in the U.S. of the IZERVAY™ (avacincaptad pegol...

Accelerating the Growth of Globally Active Drug-Discovery Startups from Japan Tokyo, 13 June 2025—Mitsubishi Research Institute, Inc. (“MRI”) and Astellas Pharma Inc. (“Astellas”) today...

- Agreement grants Astellas exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 - - XNW27011 has demonstrated...

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% After a median follow-up of 61.4 months,...

16 abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolio TOKYO, May 19, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki...

TOKYO, May 15, 2025– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today announced that at the meeting of the Board of Directors held today, a resolution...

TOKYO, May 15, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors held today, a resolution was...

TOKYO, May 7, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that during a meeting of its Board of Directors held today, it decided a...

ARVO and RWC abstracts feature analyses on biomarkers, mechanism of disease, patient experience and other data from IZERVAYTM (avacincaptad pegol intravitreal solution) pivotal studies TOKYO, May...

TOKYO, April 25, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it booked Change in fair value of contingent consideration as...

TOKYO, April 2, 2025 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Japanese Foundation for Cancer Research (Chairman: Toshio Asano, Ph.D., “JFCR”)...

TOKYO, March 6, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and YASKAWA Electric Corporation (TSE: 6506, President and CEO; Masahiro Ogawa, “YASKAWA”)...

TOKYO, February 13, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™...

TOKYO and NEW YORK, February 12, 2025 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39)...

TOKYO, February 5, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it recorded extraordinary losses in the non-consolidated financial results as below....

TOKYO, February 5, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW)...

TOKYO, February 4, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the following changes to its management structure effective April 1, 2025....

TOKYO, January 24, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the financial forecast for fiscal year 2024 announced on October 30, 2024...

TOKYO, January 9, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application...

TOKYO, January 8, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved...

TOKYO, Jan. 06, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab)...

TOKYO and RICHMOND, California, December 19, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company...

TOKYO, Nov. 19, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on November 15...

TOKYO, October 30, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has booked a foreign exchange gain of ¥1.9 billion as other income for the first quarter ...

TOKYO, Oct 28, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the company's decision to withdraw its marketing authorization application from the European Medicines...

TOKYO, Oct. 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in...

TOKYO, October 10, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that VEOZA™ (fezolinetant)*, its first-in-class treatment for moderate to severe vasomotor symptoms...

LONDON, and TOKYO, - Oct 8, 2024 – AviadoBio Ltd. (“AviadoBio”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced an exclusive option and license agreement for AVB-101...