Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
Pembrolizumab has shown meaningful benefit only when combined with chemotherapy
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38
The cancellation underscores the regulator’s strict stance against misleading cosmetic claims
The study focused on patients without actionable genomic alterations whose disease had progressed after prior immunotherapy and platinum-based chemotherapy
The initiative is focused on a problem that continues to plague cancer outcomes in India
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