FDA Grants Priority Review to Roche’s Early-Stage Breast Cancer NDA
Roche RHHBY announced that the FDA has accepted its new drug application (NDA) for its investigational candidate, giredestrant, as…
Roche to present new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer
F. Hoffmann-La Roche Ltd New giredestrant data from the lidERA study on its potential as a new standard…
Roche to present new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer
F. Hoffmann-La Roche Ltd New giredestrant data from the lidERA study on its potential as a new standard…
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase III persevERA study in ER-positive advanced breast cancer
F. Hoffmann-La Roche Ltd persevERA Breast Cancer study did not meet the primary objective of a statistically significant…
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
F. Hoffmann-La Roche Ltd Filing acceptance based on phase III data showing giredestrant plus everolimus reduced the risk…
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
F. Hoffmann-La Roche Ltd Filing acceptance based on phase III data showing giredestrant plus everolimus reduced the risk…
Roche’s phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer
F. Hoffmann-La Roche Ltd Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and…
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
F. Hoffmann-La Roche Ltd Filing acceptance based on phase III data showing giredestrant plus everolimus reduced the risk…
RHHBY Reports Positive Phase III Data on Breast Cancer Drug
Roche RHHBY announced positive data from the late-stage lidERA Breast Cancer study on pipeline candidate giredestrant. Giredestrant is…