Drug Approval | July 26, 2024
Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The inspections concluded with no Form 483 observations or significant critical findings
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
For use with Hamamatsu Images acquired with the NanoZoomer S360MD slide scanner
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