U.S. FDA grants priority review for spesolimab in GPP
U.S. FDA grants priority review for spesolimab in the treatment of patients with generalized pustular psoriasis
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Semintra®
4mg/ml – Management of chronic kidney disease (CKD) in cats: for reduction of proteinuria associated with CKD in cats. 10mg/ml – Hypertension: indicated for the treatment (EU)/control (US) of feline systemic hypertension.
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European Commission approves SPEVIGO® (spesolimab) for generalized pustular psoriasis flares
European Commission grants marketing authorization for spesolimab, the first specific treatment option for generalized pustular psoriasis flares in adults
CHMP recommends conditional approval for first GPP treatment
CHMP recommends conditional marketing authorization for novel IL-36 receptor monoclonal antibody, spesolimab, as first treatment for generalized pustular psoriasis flares
U.S. FDA approves first treatment for generalized pustular psoriasis flares in adults
Boehringer Ingelheim announces the U.S. FDA has approved the first treatment for generalized pustular psoriasis (GPP) flares in adults
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Breakthrough Designation granted in US and China
SPEVIGO® granted Breakthrough Therapy Designation in the U.S. for the prevention of generalized pustular psoriasis flares
EMA filing acceptance and validation for spesolimab
The European Medicines Agency has accepted and validated the marketing authorization application for spesolimab in generalized pustular psoriasis