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TOKYO, April12, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it expects to book approximately ¥70.0 billion in the fourth quarter of fiscal year 2023 for an impairment loss for intangible assets and change in fair value of contingent consideration...
TOKYO, April 1, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it received notification from the U.S. Food and Drug Administration (FDA) of acceptance of the company’s supplemental New Drug Application (sNDA) to include positive...
TOKYO, March 28, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for...
TOKYO, March 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients...
Read more about Astellas’ VYLOYTM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer
TOKYO, March 22, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDITM (enzalutamide) as monotherapy...
TOKYO, March 4, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms...
TOKYO and BOSTON, Mass., February 15, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Kelonia Therapeutics (CEO, Founder: Kevin Friedman, Ph.D., “Kelonia”) today announced that Xyphos Biosciences, Inc., (a wholly...
TOKYO, Feb. 15, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin...
TOKYO, February 7, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following changes to its management structure effective April 1, 2024...
Read more about Astellas Makes Announcement about Management Structure
TOKYO, January 31, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced today that it has entered into a strategic collaboration with Mass General Brigham (President and CEO: Anne Klibanski, MD) that is focused on translational medicine and early development to establish...
Read more about Astellas Announces Strategic Collaboration with Mass General Brigham
TOKYO – January 31, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) on January 31 to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV™ (enfortumab vedotin...
TOKYO and NEW YORK.– Jan. 26, 2024 – Astellas Pharma Inc. (TSE:4503,President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that on Jan. 26, 2024 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin)...
TOKYO, January 8, 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 on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent...
Read more about Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Shanghai and Suzhou, TOKYO, December 28, 2023 - Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bispecific...
TOKYO, December 22, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”), and has become a wholly owned subsidiary of Astellas...
Read more about Astellas Completes Acquisition of Propella Therapeutics
TOKYO, December 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee...
TOKYO and NEW YORK – December 15, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate...
TOKYO, December 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause...
TOKYO, November 30, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of...
TOKYO and BOTHELL, Wash.– November 30, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment...
TOKYO and IBARAKI, November 16, 2023 - University of Tsukuba (President: Kyosuke Nagata) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug...
Read more about University of Tsukuba and Astellas Confirm a Strategic Partnership
TOKYO and NEW YORK, November 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI®...
TOKYO and PITTSBORO, N.C., November 15, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”) today announced that Astellas, through a US subsidiary, and Propella have entered into a merger agreement...
TOKYO, November 15, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated...
TOKYO, November 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced results from the GATHER2 Phase 3 clinical trial, demonstrating IZERVAY™ (avacincaptad pegol intravitreal solution) continued to reduce the rate of geographic atrophy (GA) lesion growth for both...
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