Sanyou Medical’s 3D‑Printed SWINGO-3D Lumbar Cage Wins FDA 510(K) – Advances Spinal Fusion Technology
Sanyou Medical (SHA: 688085) announced that its French subsidiary Implanet has received FDA 510(K) clearance for...
Product approvals
Sihuan Pharma’s Bireociclib Wins NMPA Approval for First‑Line HR+/HER2‑ Breast Cancer – CDK2/4/6 Inhibitor Expands Label
Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that Xuanyuening (bireociclib), a Category 1 CDK2/4/6 inhibitor developed...
Bio-Thera’s Stelara Biosimilar Usymro Wins UK Approval – Expands European Market Access via Gedeon Richter
Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)...
Asieris Pharma’s Cevira Wins NMPA Approval – World’s First Non‑Surgical Photodynamic Therapy for Cervical Lesions
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176), a urogenital cancer specialist, announced marketing approval from China’s...
Hua Medicine’s Dorzagliatin Wins Hong Kong Approval – First‑in‑Class GKA Enters Market for Type 2 Diabetes
Hua Medicine (HKG: 2552) announced that the Department of Health in Hong Kong has approved HuaTangNing...
Sino Biopharma’s Rovadicitinib Wins NMPA Approval – First‑in‑Class JAK/ROCK Inhibitor for Myelofibrosis
Sino Biopharmaceutical Limited (HKG: 1177) announced that the National Medical Products Administration (NMPA) has approved rovadicitinib...
Hangyu Pharma’s Sosimerasib Wins NMPA Approval – First KRAS G12C Inhibitor for Post‑Therapy NSCLC in China
Zhejiang Hangyu Pharmaceutical Co., Ltd., a subsidiary of Jemincare, announced that China’s National Medical Products...
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...
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...
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...
CanSino Biologics Wins NMPA Approval for Menhycia Age Expansion – MCV4 Now Covers Children Up to 6 Years
CanSino Biologics (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has approved a supplementary...
J&J’s RYBREVANT SC Dosing Approved by EC – Expands Subcutaneous Options Across All NSCLC Indications
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved an extension...
Sino Biopharma’s Benmelstobart Secures Fourth NMPA Approval for Stage III NSCLC – Expanding PD‑L1 Franchise in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart, a Category 1 innovative humanized anti‑PD‑L1 monoclonal antibody...
Mabworks’ Obexelimab β Wins NMPA Approval as First Domestic NMOSD Therapy
Beijing Mabworks Biotech Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved...
Astellas’ VENTANA CLDN18 Assay Wins NMPA Approval as First Companion Diagnostic for VYLOY
Astellas Pharma Inc. (TYO: 4503) announced that its VENTANA CLDN18 (43-14A) Assay has received approval...
3SBio’s Amdokitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Bio-Thera’s Gotenfia Wins European Approval as Simponi Biosimilar
Bio-Thera Solutions Inc. (SHA: 688177) announced that the European Commission (EC) has approved Gotenfia (BAT2506), its...
Novocure’s Optune Pax Wins FDA Approval for Pancreatic Cancer; Zai Lab China Rights in Play
Novocure Ltd. (NASDAQ: NVCR), Zai Lab Ltd.’s (NASDAQ: ZLAB, HKG: 9688) Swiss oncology partner, announced FDA clearance for...