New Drug Application
Feb 06, 2024
4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016
4DMT Presents Positive Interim Data from Randomized Phase II PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD 4D Molecular Therapeutics, a prominent company in the field of genetic medicines with a focus on harnessing the full potential of geneti...
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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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