FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The trial targeted a patient population with high BMI and extensive skin involvement, averaging over 39 kg/m²
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
Each company will share operational data with Evinova, feeding the platform’s AI engines to provide benchmarks and actionable insights, aiming to speed up trials while maintaining top-tier patient care
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
Dr Adams’ lab recently uncovered a novel cellular detoxification pathway driving Cisplatin resistance in NSCLC
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
Backed by a multi-hundred-million-dollar investment, the expansion underscores Sanofi’s long-term commitment to India’s thriving life sciences ecosystem
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