FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients
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 approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
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
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
ANYRA is India’s first indigenously developed Aflibercept 2 mg biosimilar
Wegovy is now offered in six weekly doses in the EU: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and the newly approved 7.2 mg dose
This transaction fundamentally strengthens Scinai's CDMO platform
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN
The enhancements will improve environmental sustainability, strengthen material governance, and boost utility reliability
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