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News about "US FDA priority review"
US FDA and EMA Accept Cemdisiran Regulatory Submissions for Generalised Myasthenia Gravis
The FDA and EMA have accepted regulatory submissions for cemdisiran to treat generalised Myasthenia Gravis (gMG). If approved, it could become the first siRNA therapy for gMG with convenient quarterly subcutaneous dosing.
US FDA Priority Review | 25/06/2026 | By News Bureau | 113
US FDA Approves Pfizer's HYMPAVZI for Treatment of Additional Hemophilia A and B Patients
Pfizer’s HYMPAVZI has received expanded US FDA approval for hemophilia A and B patients aged 12 years and older with inhibitors, as well as children aged 6-11 years with or without inhibitors. The approval makes HYMPAVZI the first subcutaneous non-factor therapy available for pediatric hemophilia B patients ages 6 to 11 years old.
US FDA Priority Review | 09/06/2026 | By News Bureau
US FDA Grants Priority Review to Zydus Therapeutics' Saroglitazar for Primary Biliary Cholangitis
Zydus Therapeutics has received US FDA Priority Review (PR) for its New Drug Application (NDA) for saroglitazar in the treatment of Primary Biliary Cholangitis (PBC), supported by phase 3 EPICS-III trial results demonstrating significant biochemical response, with detailed data to be presented at the EASL Congress 2026.
US FDA Priority Review | 29/05/2026 | 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.
US FDA Priority Review | 22/05/2026 | By News Bureau
Bayer Wins US FDA Priority Review for Asundexian Stroke Prevention Therapy
Bayer receives US Food and Drug Administration Priority Review (PR) for asundexian to reduce recurrent stroke risk after non-cardioembolic ischemic stroke or transient ischemic attack, supported by positive phase 3 OCEANIC-STROKE trial results.
US FDA Priority Review | 20/05/2026 | By News Bureau | 102
LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease
LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.
US FDA Priority Review | 11/05/2026 | By News Bureau | 122
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.
US FDA Priority Review | 25/09/2025 | By Dineshwori | 175
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