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News about "FDA priority review"
FDA Grants Priority Review to Sanofi's Venglustat for Type 3 Gaucher Disease
Sanofi’s brain-penetrant investigational therapy venglustat has received FDA priority review after phase 3 data demonstrated positive efficacy and safety outcomes in patients with type 3 Gaucher disease.
FDA Priority Review | 29/05/2026 | By News Bureau
US FDA Grants Priority Review to HYRNUO for HER2-Mutated NSCLC
The US FDA has granted Priority Review (PR) to HYRNUO (sevabertinib) as a first-line treatment for HER2-mutated Non-Small Cell Lung Cancer (NSCLC), based on phase 1/2 SOHO-01 trial data.
FDA Priority Review | 21/05/2026 | By News Bureau
U.S. Food and Drug Administration grants Priority Review and Breakthrough Therapy status to combination therapy showing significant survival benefits in advanced HER2-positive gastric and esophageal cancers.
FDA Priority Review | 01/05/2026 | By News Bureau
FDA Grants Priority Review to Astellas and Pfizer's Bladder Cancer Combination Therapy
Astellas and Pfizer’s Padcev-Keytruda combination moves closer to expanded approval, offering a potential new treatment option to reduce recurrence and improve survival in bladder cancer patients.
FDA Priority Review | 21/04/2026 | By News Bureau
Ifinatamab Deruxtecan Gets US Priority Review for Small Cell Lung Cancer
Ifinatamab deruxtecan receives US Priority Review for Small Cell Lung Cancer, supported by Phase 2 data, with potential as a first-in-class B7-H3 targeted Antibody Drug Conjugate.
FDA Priority Review | 13/04/2026 | By News Bureau | 148
Phase 3 results show Dupixent significantly improved nasal symptoms and sinus health in patients aged six and above with allergic fungal rhinosinusitis, supporting its FDA priority review.
FDA Priority Review | 10/11/2025 | By Dineshwori | 263
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