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
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
New Phase II data show vast majority of patients experiencing no relapses or disability progression
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
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
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness
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