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News about "FDA priority review"
US FDA Accepts NDA for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancer
The US FDA has accepted Genentech’s New Drug Application (NDA) for giredestrant, an investigational oral SERD for ER-positive early-stage breast cancer. Supported by positive phase 3 trial results, giredestrant is the first and only oral SERD to demonstrate efficacy in the curative setting.
FDA Priority Review | 03/06/2026 | By News Bureau
Bristol Myers Squibb Secures FDA Priority Review for Camzyos
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental New Drug Application (NDA) for Priority Review (PR) of Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
FDA Priority Review | 02/06/2026 | By News Bureau
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 | 102
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 | 157
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 | 274
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