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News about "supplemental New Drug Application"
Karyopharm Therapeutics plans to file an sNDA with the US FDA seeking accelerated approval for selinexor in combination with ruxolitinib for myelofibrosis. Supported by positive Phase 3 SENTRY trial results, the combination has the potential to become the first approved frontline combination therapy for the rare blood cancer.
Supplemental New Drug Application | 03/08/2026 | By News Bureau | 225
FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer
Pfizer’s Talzenna-Xtandi combination receives FDA Priority Review for HRR gene-altered metastatic castration-sensitive prostate cancer, with Phase 3 data demonstrating a 52 percent reduction in the risk of disease progression or death.
Supplemental New Drug Application | 24/07/2026 | By News Bureau
Bayer Receives FDA Priority Review for Kerendia in Type 1 Diabetes-Related Kidney Disease
Bayer receives US Food and Drug Administration (FDA) Priority Review (PR) for supplemental approval of Kerendia to treat adults with Type 1 Diabetes (T1D) and Chronic Kidney Disease (CKD), potentially becoming the first Mineralocorticoid Receptor Antagonist (MRA) approved for this patient population.
Supplemental New Drug Application | 22/05/2026 | By News Bureau | 117
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