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We are Roche
A healthier future. It’s what drives us to innovate.
To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
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Identifying high-risk patients
We will prevent diseases by identifying high-risk patients early to enable timely use of medicines.
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Halting disease progression
We will stop diseases by accurately diagnosing and stratifying patients to halt disease progression through targeted medicines.
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Restoring health through medicines
We will cure diseases by identifying the cause of disease in order to restore health through curative medicines.
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FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
Basel, 20 February 2026 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen.
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