12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (Hernexeos; kinase inhibitor) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. The approval is based on data from the Phase 1b Bea