News | January 01, 2026
Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation
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
The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy
Data show adjuvant Verzenio plus endocrine therapy extends overall survival and sustains long-term improvements in invasive disease-free survival
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival
While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage
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