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FDA Accepts Roche NDA for Giredestrant in ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.

FDA Accepts Roche's Giredestrant Filing for ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.

U.S. Orphan Drug Market Projected to Reach $200 Billion by 2031

Feb 18, 2026

The U.S. orphan drug market is projected to exceed $200 billion by 2031, driven by innovation in oncology and genetic disorders. More than 1,400 FDA-designated orphan drugs are in development or marketed, with over 800 currently in clinical trials.

Roche's Gazyva Meets Primary Endpoint in Phase III Kidney Disease Trial

Feb 16, 2026

Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.