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 data highlights its RSV vaccine cuts hospitalizations in older adults
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
The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN
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
Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
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