ICOTYDE
Mar 24, 2026
Sanofi’s Venglustat Gains US Breakthrough Therapy Nod, Boosting Hope for Type 3 Gaucher Disease; Rhythm Pharmaceuticals Expands IMCIVREE Label with FDA Approval in Hypothalamic Obesity; FDA Approves LYNAVOY for Cholestatic Pruritus in PBC Patients; FDA Greenlights J&J/Protagonist’s ICOTYDE, Redefining First-Line Systemic Therapy for Plaque Psoriasis; Novartis Strengthens its Breast Cancer Portfolio Through Acquisition of a Pan-mutant PI3Kα Inhibitor
Sanofi Wins US Breakthrough Therapy Tag for Venglustat in Type 3 Gaucher Disease The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), for treating neurological symptoms associated with type 3 Gauc...
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Mar 23, 2026
J&J and Protagonist’s ICOTYDE Ushers in First-in-Class Oral IL-23 Therapy
Summary Johnson & Johnson and Protagonist Therapeutics received U.S. FDA approval for ICOTYDE (icotrokinra), the first targeted oral IL-23 receptor peptide therapy for moderate-to-severe plaque psoriasis in adults and adolescents (12+ years, ≥40 kg). Once-daily 200 mg oral tablet blocks IL-23 signaling w...
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