Hansoh Pharma’s Mirdametinib Plus Almonertinib NDA Accepted by NMPA – Dual‑Target Combination for EGFR‑Mutant NSCLC
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that China’s National Medical Products Administration (NMPA) has...
Drug
Dupixent Wins Two NMPA Approvals in China – First Biologic for Bullous Pemphigoid and Pediatric Asthma Expansion
Sanofi (NASDAQ: SNY) announced that Dupixent (dupilumab) has been approved by China’s National Medical Products Administration...
Olumiant Wins CHMP Positive Opinion for Pediatric Alopecia – JAK Inhibitor Nears EU Approval for Teens with Severe AA
Eli Lilly (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the European Medicines Agency’s (EMA) Committee for...
Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Shionogi Files CORECTIM Lotion for Japan Approval – Expands Topical JAK Inhibitor Franchise in Atopic Dermatitis
Shionogi & Co., Ltd. and subsidiary Torii Pharmaceutical Co., Ltd. announced the submission of a...
Dupixent Wins CHMP Positive Opinion for Pediatric CSU – EU Approval Nears for Children Aged 2–11 Years
Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human...
Asieris’ APL-1702 MAA Accepted by EMA – First Photodynamic Therapy for Cervical HSIL Nears EU Approval
Asieris Pharmaceuticals (SHA: 688176) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
Novartis’ Remibrutinib Wins CHMP Positive Opinion – Oral BTK Inhibitor Nears EU Approval for Chronic Urticaria
Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the...
Gan & Lee’s Insulin Biosimilars Win CHMP Positive Opinion – Bysumlog and Dazparda Near EU Market Entry
Gan & Lee Pharmaceuticals (SHA: 603087) and its European subsidiary Gan & Lee Europe announced that...
Kanghong Pharma’s Orexin Antagonist KHN707 Cleared for Insomnia Trials – First-in-Class Sleep Disorder Candidate
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced receiving clinical trial approval from China’s National...
Akeso’s Manfidokimab NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Akeso, Inc. (HKG: 9926) announced that China’s National Medical Products Administration (NMPA) has formally accepted the...
Jumpcan Pharma Secures China Rights to Thederma’s TAP-1503 – First AhR Modulator for Atopic Dermatitis
Jumpcan Pharmaceutical (SHA: 600566) announced a cooperation agreement with Shanghai‑based Thederma, securing exclusive commercialization rights in...
FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
Fosun Pharma’s Luvometinib Cleared for Phase II NSCLC Combination Trial – MEK Inhibitor Plus Anlotinib Targets KRAS Mutations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced NMPA approval to initiate a Phase...
3SBio’s SSGJ-611 NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Kexing Biopharma’s GB19 Wins NMPA IND Approval – Novel BDCA2 Targeted Therapy for Lupus Enters Clinic
Kexing Biopharma (SHA: 688136) announced that China’s National Medical Products Administration (NMPA) has cleared GB19 Injection...
Lepu Biopharma’s GPC3 ADC MRG006A Wins NMPA Approval for HCC Combination Trials – First‑in‑Class Asset Advances
Lepu Biopharma Co., Ltd (HKG: 2157) announced that China’s National Medical Products Administration (NMPA) has approved...
FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen
AstraZeneca (AZ, NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the...
Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label
Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...