This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
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
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
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
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Imfinzi also recommended for patients with mismatch repair deficient disease
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
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