The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China
The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit
This is the first controlled pharmacologic study to demonstrate that treatment of obesity improved PsA disease measures
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
Cidara will become a wholly owned subsidiary of Merck and the common stock of Cidara will no longer be listed or traded on the Nasdaq Global Market
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
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