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News about "NDA submission"
Xenon Submits NDA for Azetukalner in Focal Seizures to US FDA
Xenon Pharmaceuticals has submitted an NDA to the US FDA for azetukalner in focal seizures, supported by data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials.
NDA Submission | 21/09/2026 | By News Bureau | 112
Xenon Submits NDA for Azetukalner in Focal Seizures to US FDA
Xenon Pharmaceuticals has submitted an NDA to the US FDA for azetukalner in focal seizures, supported by data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials.
NDA Submission | 21/09/2026 | By News Bureau | 112
Teva Completes Acquisition of Emalex Biosciences
Teva has completed its acquisition of Emalex Biosciences, strengthening its late-stage neuroscience pipeline. The deal supports Teva’s Pivot to Growth strategy.
NDA Submission | 12/06/2026 | By News Bureau | 189
Nuvalent Submits NDA to FDA for Neladalkib in Advanced ALK-Positive Lung Cancer
The investigational ALK inhibitor, backed by Phase I/II trial data, targets treatment-resistant non-small cell lung cancer and has received breakthrough and orphan drug designations.
NDA Submission | 08/04/2026 | By News Bureau | 187
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