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647,241 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
Approvals
Astellas’ First-in-Class, Claudin-Targeted Therapy Wins FDA Nod for Certain Gastric Cancers
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
October 21, 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
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
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
Layoffs
Astellas Cuts 24 Universal Cells Roles in Seattle, Transfers 12 to Japan
Astellas is opening a second location of Universal Cells, its wholly owned subsidiary, at a research campus in Japan and transferring 12 roles from Universal’s Seattle location.
October 10, 2024
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1 min read
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Angela Gabriel
FDA
Astellas’ VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
October 18, 2024
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19 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
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