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
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program
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
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
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
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