Roche Gets FDA Priority Tag for Enspryng in Rare Autoimmune Disorder
RHHBY's sBLA for Enspryng wins FDA priority tag for myelin oligodendrocyte glycoprotein antibody-associated disease. A decision is due on Jan. 10, 2027.
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Novartis' Del-desiran Fails Late-Stage DM1 Study, Shares Fall
NVS' del-desiran fails the HARBOR study's primary endpoint, adding to recent pipeline setbacks as investors await next steps.
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FDA Accepts & Gives Priority Review to Intellia's BLA for HAE Drug
NTLA's BLA for lonvo-z wins FDA priority review for the treatment of HAE. A decision from the agency is expected by March 10, 2027.
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ABBV's Etentamig Meets Goals in Phase III Multiple Myeloma Study
AbbVie's etentamig meets key phase III goals in multiple myeloma, improving response rates and progression-free survival versus standard therapies.
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TEVA's TEV '408 Meets Goal in Phase IIa Celiac Disease Study
Teva's TEV '408 meets its phase IIa celiac disease goal, preventing gluten-induced intestinal damage and showing a favorable safety profile.
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QURE Submits Application for Gene Therapy for Huntington's Disease
QURE seeks accelerated FDA approval for AMT-130, with Priority Review and a U.K. filing adding momentum to its regulatory push.
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Novartis' Remibrutinib Delivers Positive Results in Late-Stage MS Studies
Novartis' remibrutinib delivers positive phase III RMS results, reducing relapse rates versus Aubagio and supporting plans for global regulatory approvals.
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GSK to Advance mRNA Influenza Vaccine Into Phase III Development
GSK to advance its mRNA flu vaccine into phase III after phase II study has shown stronger immune responses and good tolerability.
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OCGN Advances Gene Therapy OCU410 In Phase III for Geographic Atrophy
Ocugen moves OCU410 into phase III for geographic atrophy, with FDA-aligned study plans. The company expects to file a BLA for OCU410 in 2028.
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Axsome Begins Phase III Study on AXS-05 for Smoking Cessation
AXSM begins dosing in the phase III SUMMIT study investigating AXS-05 for treating smoking cessation in adults.