FDA accepted Teva's NDA for TEV-'749, an investigational once-monthly subcutaneous olanzapine injection for schizophrenia in adults, on February 20, 2026, supported by Phase 3 SOLARIS Week 56 data showing efficacy and safety consistent with existing formulations and no need for post-injection monitoring.1
FDA accepted Roche's NDA for giredestrant combined with everolimus for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer post-endocrine therapy, with a target action date of December 18, 2026; Phase 3 evERA data showed 44% reduced risk of progression or death in ITT population and 62% in ESR1-mutated patients.23
Recent biopharma updates include FDA reviews of Roche and Teva NDAs plus funding for Candel's immunotherapy, as highlighted in industry news on February 20, 2026.6
Sources:
1. https://www.stocktitan.net/news/TEVA/u-s-food-and-drug-administration-fda-accepts-teva-s-new-drug-opdn85nx3jq1.html
2. https://www.nasdaq.com/articles/fda-accepts-roches-nda-seeking-approval-breast-cancer-drug
3. https://www.pharmaceutical-technology.com/news/roche-receives-fda-acceptance-giredestrant/