News about "US FDA priority review"

US FDA Accepts BridgeBio's Infigratinib NDA for Achondroplasia

BridgeBio has announced the US FDA acceptance and Priority Review (PR) of New Drug Application (NDA) for oral infigratinib for children with achondroplasia.

US FDA Priority Review | 08/10/2026 | By News Bureau |  236

US FDA Accepts NDA under Priority Review for Takeda's Zasocitinib

The US Food and Drug Administration (FDA) has accepted Takeda’s New Drug Application (NDA) for zasocitinib under Priority Review (PR) for the treatment of moderate-to-severe plaque psoriasis, potentially redefining expectations for oral treatment.

US FDA Priority Review | 15/09/2026 | By News Bureau

US FDA Grants Priority Review to Genentech?s Enspryng for MOGAD

The US Food and Drug Administration (FDA) has granted priority review to Genentech’s Enspryng for MOGAD after phase 3 METEOROID data showed a 68 percent reduction in relapse risk.

US FDA Priority Review | 11/09/2026 | By News Bureau

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 |  253

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 |  146

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 |  255

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 |  167

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 |  206

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 |  178

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 |  236