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 new lineup features everything from the Color Fixation and Hair Therapy ranges to the Balanced Cleansing Shampoo and Nourishment & Protection Conditioner
The clinical program has benefited from extensive European Union support, including the IMI2 TRIC-TB and UNITE4TB projects, as well as funding from the EDCTP2 bEto-TB project
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
The drug’s safety profile in LIBRETTO-432 aligned with previous selpercatinib studies, showing no unexpected concerns
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
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
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