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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...
TOKYO, October 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the company has ranked first in the pharmaceuticals sector for the “2023 Award for Excellence in Corporate Disclosure” granted by the Securities Analysts Association of Japan (SAAJ) to...
TOKYO and BOTHELL, Wash. – October 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination...
TOKYO, Oct 15, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company’s focus on making a meaningful difference for people living with...
Read more about Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023
TOKYO, October 13, 2023 – 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) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg...
Read more about Astellas Receives Positive CHMP Opinion for VEOZATM (fezolinetant)
TOKYO and Boston, MA October 10, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and BioLabs Global, Inc. (Founder and CEO: Johannes Fruehauf, “BioLabs”) and Mitsui Fudosan (TSE: 8801, President and CEO: Takashi Ueda, “Mitsui Fudosan”) today announced that they have agreed...
TOKYO, September 28, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following personnel change in its top management effective from...
TOKYO and BOTHELL, Wash. – September 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced positive topline results from the Phase 3 EV-302 clinical trial (also known as...
TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will share new pooled efficacy and safety analyses from the pivotal Phase 3 SKYLIGHT™ studies for VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor...
TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its New Drug...
TOKYO, September 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY™...
TOKYO, September 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million in Tralee, Co. Kerry...
TOKYO, September 12, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...
TOKYO, August 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) successfully priced a dual-tranche of series 3rd and 4th JPY denominated unsecured bonds...
Read more about Notice Regarding Issuance of Unsecured Bonds
NEW YORK and TOKYO, August 23, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies’ supplemental...
TOKYO, August 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol...
TOKYO and SAN FRANCISCO, August 9, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to open a new state-of-the-art life sciences facility at 441 Morgan Avenue, in the Cambridge Crossing...
TOKYO and SAN DIEGO, August, 7, 2023 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, CEO: Mark Gergen, "Poseida") today announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy...
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