Highlights: Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the…
Monthly Archives
September 2022
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RegulatoryU.S FDA
QOL Medical, LLC receives FDA approval of Sucraid® (Sacrosidase) Oral Solution single-use containers for Patients with Congenital Sucrase-Isomaltase Deficiency (CSID)
by adminby adminQOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers…
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RegulatoryU.S FDAVertex
Vertex Announces U.S. FDA Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to 24 months
by adminby adminSummary: Orkambi was first approved in 2015 in the US and is now available in more than 30 countries. Vertex Pharmaceuticals Incorporated…
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Boehringer IngelheimRegulatoryU.S FDA
Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)
by adminby adminSynopsis: German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised…
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RegulatorySanofi Inc.U.S FDA
XenpozymeTM (Olipudase alfa-rpcp) Approved by FDA as First Disease-Specific Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease to Sanofi
by adminby adminSummary: XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations) Xenpozyme is the first approved medication to treat symptoms that are not related…
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