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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.
Prescription Drug User Fee Act | 03/08/2026 | By News Bureau | 242
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.
Prescription Drug User Fee Act | 24/07/2026 | By News Bureau
Viatris Inc sNDA for MR-141 Accepted by U.S. Food and Drug Administration for Presbyopia Treatment
The US FDA has accepted Viatris’ supplemental application for phentolamine ophthalmic solution 0.75 percent to treat presbyopia and advancing to a potential non-invasive therapy.
Prescription Drug User Fee Act | 02/03/2026 | By News Bureau | 197
FDA Accepts for Review INOVIO BLA for INO-3107 in RRP
The US FDA has accepted for review INOVIO’s Biologics Licence Application (BLA) for INO-3107 for the treatment of adults with Recurrent Respiratory Apillomatosis (RRA), assigning a PDUFA action date of 30 October, 2026, and indicating that it does not currently plan to convene an advisory committee meeting for the application.
Prescription Drug User Fee Act | 31/12/2025 | By News Bureau | 263
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Prescription Drug User Fee Act | 25/09/2025 | By Dineshwori | 210
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