News Related to Roche

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RNA-Targeting Small Molecules Gain Momentum as Drug Discovery Frontier

Feb 27, 2026

Pharmaceutical companies are increasingly partnering with biotechs developing RNA-targeting small molecules, driven by advances in RNA structural biology and the success of drugs like Roche's Evrysdi. The approach aims to address "undruggable" targets while offering oral availability advantages.

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.