Drug Approval | December 06, 2024
FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
For people with relapsed or refractory diffuse large B-cell lymphoma
For people with relapsed or refractory diffuse large B-cell lymphoma
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
CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone
Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen
Innovent will supply sintilimab for the collaborated clinical trial
Elpiscience will receive up to US $37 million, including the upfront payment and license option fees
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
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