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FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections

– No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified in the UDENYCA® ONBODY™ CRL – – No...
United States Marek Ciszewski Coherus Biosciences Jodi Sievers Theresa Lavallee Development Officer

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Coherus BioSciences Reports Second Quarter 2023 Financial Results and Business Highlights

02.08.2023 - – Net revenue rose 81% from prior quarter to $58.7 million –– CIMERLI net sales quadrupled to $26.7 million compared to prior quarter –– UDENYCA autoinjector launched in late May, and YUSIMRY launched in July –– Planned merger with Surface Oncology ...
United States Junshi Biosciences Jodi Sievers Denny Lanfear Klinge Pharma Coherus Biosciences

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