Coherus Announces U.S. Launch of UDENYCA ONBODY™ a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv – Innovative design enables five-minute pegfilgrastim-cbqv delivery time – – Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...

Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv – Innovative design enables five-minute pegfilgrastim delivery time – – Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...

Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™ – Resubmission follows the satisfactory resolution of the FDA’s review of inspection findings at the third-party filler – REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Coherus...

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 additional...