Drug Approval | February 21, 2026
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 FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
The partnership will launch a Phase 1b cohort within Boehringer’s ongoing Beamion-BCGC1 trial
Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
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