BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
NCFB is a chronic lung condition where damaged airways cause persistent coughing and mucus production
In 2025, over 1 million patients accessed Lilly treatments through LillyDirect
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
Both non-transfusion-dependent and transfusion dependent cohorts met their respective primary and secondary endpoints
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
The data highlights its RSV vaccine cuts hospitalizations in older adults
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