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BRIEF-Coherus, Junshi Biosciences Receive Complete Response Letter From U.S. FDA For Toripalimab BLA

reuters.com · 05/02/2022 07:23
BRIEF-Coherus, Junshi Biosciences Receive Complete Response Letter From U.S. FDA For Toripalimab BLA

- Coherus BioSciences Inc CHRS:

  • COHERUS AND JUNSHI BIOSCIENCES RECEIVE COMPLETE RESPONSE LETTER FROM U.S. FDA FOR TORIPALIMAB BLA

  • COHERUS AND JUNSHI BIOSCIENCES RECEIVE COMPLETE RESPONSE LETTER FROM U.S. FDA FOR TORIPALIMAB BLA

  • COHERUS BIOSCIENCES INC - CRL REQUESTS A QUALITY PROCESS CHANGE COHERUS AND JUNSHI BELIEVE IS READILY ADDRESSABLE

  • COHERUS BIOSCIENCES INC - BLA RESUBMISSION ANTICIPATED BY MID-SUMMER 2022 WITH EXPECTED SIX MONTH FDA REVIEW TIMELINE

  • COHERUS BIOSCIENCES INC - ONSITE INSPECTIONS IN CHINA, IMPEDED TO DATE BY COVID-19-RELATED TRAVEL RESTRICTIONS, ARE REQUIRED FOR FDA'S COMPLETION OF BLA REVIEW

  • COHERUS BIOSCIENCES INC - TORIPALIMAB WILL BE FIRST AND ONLY IMMUNO-ONCOLOGY AGENT FOR NPC IN U.S., IF APPROVED

Source text for Eikon: ID:nGNX6QyVNP

Further company coverage: CHRS


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