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642,809 Results for "astellas pharma us".
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Business
Astellas Pharma Opens Cambridge Life Sciences Center Featuring Incubator Space
Astellas Pharma’s new life sciences center houses its first U.S.-based SakuLab, an incubator space for external partners, as well as its engineered small molecules unit.
September 6, 2024
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1 min read
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Angela Gabriel
FDA
Astellas’ Hot Flash Drug Veozah Slapped With Another FDA Warning for Liver Injury
One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label.
September 13, 2024
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2 min read
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Tristan Manalac
BioMidwest
Astellas Names Michael Petroutsas as Head of US Commercial
Astellas Pharma Inc. Chief Commercial Officer Claus Zieler has named Michael Petroutsas as Head, United States Commercial, leading the Astellas Pharma US Inc. organization.
February 22, 2024
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2 min read
Business
Astellas Announces Sponsored Research Agreement with UMass Chan Medical School
Astellas Pharma US, Inc. (“Astellas”) announced today the company has entered into a sponsored research agreement with the UMass Chan Medical School to proceed with research for an adeno-associated virus (AAV) vector mediated gene therapy for the treatment of Alexander disease, a fatal, ultra-rare disease for which the only current treatment option is supportive care.
June 20, 2024
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5 min read
Policy
U.S. FDA Acknowledges Astellas’ Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date
Astellas Pharma Inc. announced that the U.S. FDA has acknowledged the company’s resubmission of the BLA for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 -negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
May 30, 2024
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12 min read
Business
Vivtex Enters Research Collaboration with Astellas Pharma
Vivtex Corporation announces that it has entered a research collaboration with Astellas Pharma Inc. (“Astellas”), a global pharmaceutical company.
January 23, 2024
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2 min read
FDA
Verona Pharma Announces US FDA Approval of Ohtuvayre™ (ensifentrine)
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
June 26, 2024
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10 min read
BioMidwest
Invenra Inc. Announces a Strategic Research Agreement with Astellas Pharma in Therapeutic Bispecific Antibody Discovery
Invenra Inc., an innovative leader in bispecific antibody technology, is pleased to announce a strategic research agreement with Astellas Pharma, a global pharmaceutical company with a vision to turn innovative science into value for patients.
April 9, 2024
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1 min read
Astellas’ XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
April 23, 2024
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11 min read
Layoffs
Astellas Gene Therapies to Close Biomanufacturing Facility, Affecting About 100 Employees
Astellas Gene Therapies is closing its San Francisco biomanufacturing facility, shifting gene therapy manufacturing to North Carolina, cutting at least 17 employees and affecting dozens more.
September 3, 2024
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1 min read
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Angela Gabriel
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