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FDA Accepts Astellas’ New Drug Application for Fezolinetant

Aug 19, 2022
Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for fezolinetant, an investigational oral,…
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Atomwise Signs Strategic Multi-Target Research Collaboration with Sanofi for AI-Powered Drug…

Aug 19, 2022
Atomwise announced that it has established a strategic and exclusive research collaboration with Sanofi that will leverage its AtomNet platform for computational discovery and research…
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European Commission Approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for…

Aug 19, 2022
Celltrion Healthcare announced that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of…
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Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for…

Aug 18, 2022
Nuance Pharma announces the Center for Drug Evaluation has approved its Investigational New Drug application supporting its pivotal clinical trial of Ensifentrine for the maintenance…
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Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot…

Aug 18, 2022
Valneva SE announces that it has initiated rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the Company’s…
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Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand as a First…

Aug 18, 2022
Novavax, Inc. announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus…
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Key Presentations at the Medical Devices & IVD Conference Released

Aug 18, 2022
SAE Media Group reports: ahead of the conference in November, key presentations are released for the Medical Devices & IVD Conference  Launching for the first time in London, UK…
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bluebird bio Announces FDA Approval of ZYNTEGLO, the First Gene Therapy for People with…

Aug 17, 2022
bluebird bio, Inc. announced the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy…
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WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware

Aug 17, 2022
WuXi STA, a leading Contract Research, Development, and Manufacturing Organization (CRDMO), is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing…
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RoosterBio and AGC Biologics Announce Collaboration to Accelerate Manufacturing of Cell and Exosome…

Aug 17, 2022
AGC Biologics announced a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess…
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Press Releases

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