The CALINA study tested a new ratio and dose of Coartem to account for metabolic differences in babies under 5 kg
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Submission based on results from pivotal phase III trial showing all primary endpoints met
Longest survival follow-up ever reported for immunotherapy treatment in this setting
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
The approval marks a significant milestone for the American pharmaceutical company in the field of UC
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