Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
The order will cover the manufacturing of bulk vaccine in 2026
Net sales reached CHF 1,327.8 million, up 2.6% year-on-year in Swiss francs, or 4.3% at constant exchange rates
The alliance directly links VivaMed’s computational drug hypotheses with Syngene’s preclinical development capabilities
This multi-year CDMO agreement involves significant, ongoing manufacturing for a global pharmaceutical major
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
Merck is currently conducting approximately 80 Phase 3 studies, and the company expects more than 20 new growth drivers over next several years, almost all with blockbuster potential
Our vision is to position India not just as a consumer of advanced simulation technologies but as a creator and exporter of them
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
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