Brief: Cytosorbents Files Appeal With U.S. FDA For Supervisory Review Of De Novo Request
24/06/2025 12:01
June 24 (Reuters) - Cytosorbents Corp CTSO.O: CYTOSORBENTS FILES APPEAL WITH U.S. FDA FOR SUPERVISORY REVIEW OF ITS DE NOVO REQUEST FOR DRUGSORB™-ATR CYTOSORBENTS CORP - FDA DENIAL LETTER IDENTIFIES REMAINING DEFICIENCIES FOR DRUGSORB-ATR CYTOSORBENTS CORP - FDA APPEALS PROCESS INCLUDES FORMAL HEARING, DECISION IN 60 DAYS CYTOSORBENTS CORP - HEALTH CANADA REVIEWS DELAYED DUE TO BACKLOG CYTOSORBENTS CORP - DRUGSORB-ATR APPLICATION WITH HEALTH CANADA UNDER ADVANCED REVIEW CYTOSORBENTS CORP: DRUGSORB-ATR APPLICATION WITH HEALTH CANADA REMAINS UNDER ADVANCED REVIEW CYTOSORBENTS CORP: REMAINS CONFIDENT IN RECEIVING A FINAL REGULATORY DECISION IN 2025 Source text: ID:nPn2VDthJa Further company coverage: CTSO.O ((Reuters.Briefs@thomsonreuters.com;))