Drug Approval | May 08, 2024
USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
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
Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program
NexGard Spectra is a soft, flavourful monthly chew that kills fleas before they can lay eggs
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
Sun Pharma's Dadra facility receives OAI status from US FDA
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