15/12/2025 Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer (Ref) The US FDA granted appr

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA (Ref) The National Medical Products Administration (NMPA) has accepted the sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy as a first-line treatment for advanced squamous NSCLC. The filing is based on the results from the Phase 3 AK112-306/HARMONi-6 trial, which showed that ivonescimab + chemotherapy

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)