FDA approves Biktarvy label update with data for pregnant adults with HIV
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
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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
Breakthrough Therapy designation for pain associated with DPN granted by FDA
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
Global Phase-3 study initiation expected in the second half of 2024
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