Supplemental New Drug Application
Sep 19, 2023
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®
EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...
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