FDA accepts NDA for Roche’s giredestrant

3 June 2026

Swiss pharma giant Roche (ROG: SIX) announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader (SERD).

The drug is intended as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. The FDA is expected to make a decision on the approval by 30 November 2026.

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