26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL ( Ref ) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D

Highlights from the CHMP Nov 2025 Meeting are out! New Medicines 💊  Eli Lilly and Company 's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. New Hybrid Medicines 💊  Accord Healthcare 's enzalutamide (Enzalutamide Ac

Highlights from the CHMP Oct 2025 Meeting are out! Indication Expansions 💊  Bristol Myers Squibb 's lisocabtagene maraleucel (Breyanzi; autologous CD19-directed CAR T-cell therapy) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor 💊  CStone Pharmaceuticals  and  Ewopharma 's sugemalimab (Cejemly; anti-PD-L1) as monotherapy i

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC ( Ref ) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. T

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL ( Ref ) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of...

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...