Astellas Pharma, Inc.
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Latest From Astellas Pharma, Inc.
FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.
EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval.
- Other Names / Subsidiaries
- Advanced Cell Technology, Inc.
- Agensys, Inc.
- Audentes Therapeutics, Inc.
- Fujisawa GmbH
- Ganymed Pharmaceuticals AG GmbH
- iota Biosciences
- Mytogen, Inc.
- Nanna Therapeutics Limited
- Perseid Therapeutics LLC
- Potenza Therapeutics Inc.
- Ocata Therapeutics, Inc.
- OSI Pharmaceuticals, LLC (Cell Pathways
- Yamanouchi Pharmaceutical Co., Ltd.
- Ogeda S.A.
- Mitobridge, Inc.
- Mitokyne, Inc.
- Quethera Limited
- Universal Cells, Inc.
- Xyphos Biosciences, Inc.
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