Drug Approval | September 03, 2024
Roche’s PiaSky approved in the EU for treatment of people with PNH
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
Decision on EU marketing authorisation for this population expected by September 2024
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
Ulcerative Colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) affecting the large intestine
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
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