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11.12.2025
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Astellas to Present New Clinical Data Across Its Gastrointestinal Cancers Portfolio at 2026 ASCO GI Cancers Symposium
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- 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 first-line advanced gastric and gastroesophageal junction (GEJ) cancer featured in late-breaking oral presentation -TOKYO, Dec. 10, 2025 /PRNewswire/ -- Aste...
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05.12.2025
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Astellas To Present New Data on XOSPATA™ (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting
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- 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 Phase 3 MORPHO trial in the post-transplant maintenance setting and Phase 1/2 VICEROY trial in newly diagnosed disease highlight how treatment timing, sequen...
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22.10.2025
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Astellas Presents Preliminary Real-World VEOZAH™ (fezolinetant) Data From OPTION-VMS Phase IV Observational Study
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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 study demonstrated fezolinetant leads to statistically significan...
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Worth to know
20.10.2025
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22.10.2025
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PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle-Invasive Bladder Cancer
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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 50% in cisplatin-ineligible patients with muscle-invasive bladder cancer...
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Swarmalpha i/o · The Event Futures Prediction X
20.10.2025
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20.10.2025
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IZERVAY™ (avacincaptad pegol intravitreal solution) Showed Increased Benefit in Reducing Geographic Atrophy Progression Over Time and Consistent Long-Term Safety
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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 no new safety signals and no cases of retinal vasculitis or occlu...
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15.10.2025
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Astellas to Present First Real-World VEOZAH™ (fezolinetant) Data at 2025 Annual Meeting of The Menopause Society
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TOKYO, Oct. 14, 2025 /PRNewswire/ -- 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 severe vasomotor symptoms (VMS) due to menopause, will be featured in six Astellas-s...
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09.10.2025
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Astellas to Present New Data on IZERVAY™ (avacincaptad pegol intravitreal solution) in Geographic Atrophy at AAO 2025 Annual Meeting
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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 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: N...
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01.10.2025
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Astellas To Present Pioneering Advances Across Its Portfolio and Pipeline at ESMO 2025
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- 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 cisplatin-ineligible patients with muscle invasive bladder cancer se...
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17.07.2025
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Astellas Announces a Partnership with the "Korea Institute of Startup and Entrepreneurship Development", an Umbrella Organization of the "Ministry of SMEs and Startups", a Korean Government Agency, for the Operation of the "Partnership with Global Compani
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- 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 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has agreed on a memorandum of understa...
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13.06.2025
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Mitsubishi Research Institute and Astellas Announce Collaboration to Support Pharma Startups in Japan
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Accelerating the Growth of Globally Active Drug-Discovery Startups from Japan
TOKYO, June 13, 2025 /PRNewswire/ -- Mitsubishi Research Institute, Inc. ("MRI") and Astellas Pharma Inc. ("Astellas") today announced that they have agreed on a memorandum of understanding to provide drug-discovery startups in Japan with support in their efforts to go...
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30.05.2025
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Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2
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- Agreement grants Astellas exclusive worldwide rights (excluding China's mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 -
- XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic c...
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28.05.2025
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Astellas Announces Second Annual Patient Advocacy Organization (PAO) Action Week™ To Empower Patients and Caregivers
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Building on a successful inaugural year, the initiative sponsored by Astellas' Patient Centricity team continues to connect individuals with vital resources and support from patient advocacy organizations
NORTHBROOK, Ill., May 28, 2025 /PRNewswire/ -- Astellas Patient Centricity is pleased to announce the second annual Patient Advocacy Organizati...
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20.10.2025
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21.05.2025
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Astellas and MBC BioLabs Announce the 2025 Astellas Future Innovator Prize Awarded to DeepSeq.AI & Serna Bio
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Both companies have earned a year-long opportunity for access to a distinguished life-science incubator in San Francisco along with the invaluable expertise provided by Astellas to advance their research endeavorsAward helps biotech startups accelerate early research effortsNORTHBROOK, Ill., May 21, 2025 /PRNewswire/ -- Astellas Pharma U.S. Inc....
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19.05.2025
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Astellas Presents New Data that Explores Potential of its Cancer Therapies at 2025 ASCO Annual Meeting
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16 abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio
TOKYO, May 19, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical On...
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07.05.2025
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Notice of Nominees for Directors
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TOKYO, May 7, 2025 /PRNewswire/ -- 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 change in Directors as outlined below. The appointment of Andreas Busch and Mark Enyedy as new candidates to be proposed at the 20th Term Annual...
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01.05.2025
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Astellas to Present New Data in Geographic Atrophy at Upcoming Ophthalmology Annual Congresses
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ARVO and RWC abstracts feature analyses on biomarkers, mechanism of disease, patient experience and other data from IZERVAY™ (avacincaptad pegol intravitreal solution) pivotal studies
TOKYO, May 1, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), maker of IZERVAY™ (avacincaptad pegol intravitrea...
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06.03.2025
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Astellas and YASKAWA Agree to Establish a Joint Venture Focused on Cell Therapy Manufacturing
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- Joint venture will aim to develop a cell therapy manufacturing platform through robotics and will offer access to startups and academic institutions -
TOKYO, March 5, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and YASKAWA Electric Corporation (TSE: 6506, President and CEO; Masahiro Ogawa,...
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27.02.2025
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Astellas and MBC BioLabs Announce the Sixth Annual Astellas Future Innovator Prize
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Awardees win a year of access to a prestigious life-science incubator in San Francisco and to Astellas expertise to further their researchAward helps biotech start-ups accelerate early drug discovery and research effortsNORTHBROOK, Ill., Feb. 27, 2025 /PRNewswire/ -- Astellas Pharma U.S. Inc. (Head of Commercial: Mike Petroutsas, "Astellas"), and...
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13.02.2025
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U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
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IZERVAY dosing approved beyond 12 months
TOKYO, Feb. 12, 2025 /PRNewswire/ -- 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™ (avacincaptad pegol intravitreal solution) for the treatment of geogra...
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05.02.2025
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Astellas Submits New Drug Application for Conditional Approval of Avacincaptad Pegol for Geographic Atrophy in Japan
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- Ministry of Health, Labour and Welfare to evaluate ACP as potential first and only treatment for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in Japan -
TOKYO, Feb. 5, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Naoki Okamura, "Astellas") today announced the submission o...
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04.02.2025
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Astellas Makes Announcement about Management Structure
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TOKYO, Feb. 4, 2025 /PRNewswire/ -- 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.
Regarding the Change...
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© PR Newswire
06.01.2025
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China's National Medical Products Administration (NMPA) Approves VYLOY™ (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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- China has the highest number of cases and deaths from gastric cancer of any country worldwide1 -
- Zolbetuximab is the first and only therapy approved in China to target claudin 18.2, a biomarker expressed by 35% of Chinese patients with advanced gastric and gastroesophageal junction (GEJ) cancer2 -
- Treatment with the claudin 18.2-targeted mo...
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05.12.2024
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Astellas and Dr. Jen Ashton launch "Cooler Moments" to Spotlight Menopausal Hot Flashes and Empower Women to Advocate for Themselves
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"Cooler Moments" educates and empowers women in midlife to speak up for themselves and celebrate this natural change in their lives.
NORTHBROOK, Ill., Dec. 5, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (TSE: 4503, Head of US Commercial: Michael Petroutsas, "Astellas") today announced the launch of Cooler Moments in partnership with Dr. Jen Ash...
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20.11.2024
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Astellas Announces Desert Oasis Healthcare as First Health System to Implement DIGITIVA™ for Heart Failure Management
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SAN FRANCISCO, Nov. 20, 2024 /PRNewswire/ -- Astellas Pharma U.S., Inc. (President: Mike Petroutsas, "Astellas") today announced that it has entered into an agreement with Desert Oasis Healthcare (DOHC), a member of Heritage Provider Network, to pilot DIGITIVA™, a non-invasive digital health solution for the management of heart failure patients....
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18.10.2024
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Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
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VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive
TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Admin...
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10.10.2024
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FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device
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ALAMEDA, Calif., Oct. 10, 2024 /PRNewswire/ -- iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). The EFS wi...
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10.10.2024
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Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause
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TOKYO, Oct. 10, 2024 /PRNewswire/ -- 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 (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menop...
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08.10.2024
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Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications
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Astellas receives an exclusive option to license AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development
AviadoBio receives $20 million equity investment, up to $30 million in upfront payments and is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option...
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24.09.2024
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Japan's Ministry of Health, Labour and Welfare Approves PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma
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- Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly extended progression free survival compared to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial carcinoma1
- Approval follows priority review desi...
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20.09.2024
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Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
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- Zolbetuximab is currently the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2
- Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in...
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19.09.2024
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Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure
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- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -
TOKYO, Sept. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that DIGITIVA™, a non-invasive digital health solution for h...
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11.09.2024
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Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024
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- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types -
TOKYO, Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved...
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05.09.2024
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Astellas Unveils New Life Sciences Center in Cambridge, Massachusetts to Accelerate the Discovery of Breakthrough Therapies
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The Astellas Life Sciences Center hosts the company's first U.S.-based open innovation SakuLab™ incubator space dedicated to fostering pioneering science through collaboration with external partners
TOKYO and CAMBRIDGE, Mass., Sept. 5, 2024 /PRNewswire/ -- Today, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") offic...
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04.09.2024
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Astellas to Present VEOZAH™ (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society
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- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood
- Pooled data from three SKYLIGHT™ studies assess safety and tolerability in Hispanic/Latina women
- Responder analysis from DAYLIGHT™study evaluates reduction in...
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28.08.2024
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European Commission Approves Astellas' PADCEV™ (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
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- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1
- European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1
TOKYO, Aug. 28, 2024 /PRNewswire/ -- Aste...
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27.08.2024
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Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
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HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy
Canadian team has dosed first patient in HIGHLIGHT 1™ Phase 3 study
MARKHAM, ON, Aug. 27, 2024 /CNW/ - Astellas Pharma Inc. (TSE: 4503), President...
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27.08.2024
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Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
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- HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy -
TOKYO, Aug. 27, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced dosing of th...
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20.08.2024
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China's National Medical Products Administration (NMPA) Approves PADCEV™ (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer
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- Approval based on the global EV-301 and China EV-203 trials, where enfortumab vedotin significantly improved overall survival (OS) and objective response rate (ORR) respectively in patients following prior treatment with platinum-based chemotherapy and PD-1/L1 inhibitors1,2
- Enfortumab vedotin will provide a much needed new treatment option fo...
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