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...
Tonghua Dongbao Partners with Huisheng Biopharma – Secures China Rights to First Domestic Insulin Degludec Biosimilars
Tonghua Dongbao Pharmaceuticals Co., Ltd (SHA: 600867) and Huisheng Biopharmaceutical Co., Ltd. announced a Commercialization Cooperation...
Zai Lab Reports $457M Full‑Year Revenue – 16% Growth Driven by Xacduro and Nuzyra Expansion
Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced Q4 and full‑year 2025 financial results, with net product revenue...
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...
BeOne Medicines Reports $5.3B Full‑Year Revenue – Brukinsa Drives 40% Growth, 2026 Guidance Raised
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced Q4 and full‑year 2025 financial results, with global...
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...
WuXi XDC Licenses WuXiTecan-2 Technology to Earendil Labs – $885M Deal Powers AI‑Driven ADC Development
WuXi XDC (HKG: 2268), a leading global end‑to‑end CRDMO, announced a strategic collaboration with Earendil Labs,...
MSD’s Prevymis Wins NMPA Approval for 200‑Day Pediatric CMV Prophylaxis – Extended Post‑Transplant Protection
Merck & Co. (MSD, NYSE: MRK) announced that Prevymis (letermovir), its novel non‑nucleoside cytomegalovirus (CMV) inhibitor,...
SteinCares Partners with Shilpa Biologicals on Latin America Biosimilar Deal – Regional Commercialization Agreement
SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL),...
NMPA Approves 76 Innovative Medical Devices in 2025 – 17% YoY Growth Driven by AI and Priority Review Surge
The National Medical Products Administration (NMPA) released its 2025 Annual Medical Device Registration Report, highlighting...
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...
NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog – 63 Specifications Under Review
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened...