Brief: Citius Pharma Receives U.S. FDA Guidance For Planned Resubmission Of BLA For Lymphir
08/09/2023 14:51
Sept 8 (Reuters) - Citius Pharmaceuticals Inc CTXR.O :
* CITIUS PHARMACEUTICALS, INC. RECEIVES REGULATORY GUIDANCE
FROM
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) REGARDING THE
PLANNED RESUBMISSION OF THE BLA FOR LYMPHIR™
* CITIUS PHARMACEUTICALS INC: RESUBMISSION TO FDA PLANNED
FOR
EARLY 2024
* CITIUS PHARMACEUTICALS INC- NO ADDITIONAL CLINICAL
EFFICACY OR
SAFETY TRIALS HAVE BEEN REQUESTED BY FDA FOR RESUBMISSION
* CITIUS PHARMACEUTICALS INC- CITIUS PLANS TO COMPLETE CRL
REMEDIATION ACTIVITIES BY END OF YEAR AND FILE RESUBMISSION IN
EARLY 2024
Source text for Eikon: ID:nPn90kSC3a
Further company coverage: CTXR.O
((Reuters.Briefs@thomsonreuters.com;))
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