The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
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
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
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
The NDA filing is supported by results from the phase III evERA Breast Cancer study
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
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