Novo Nordisk Secures FDA Approval for Rybelsus to Reduce Cardiovascular Risk in Type 2 Diabetes
Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration (FDA) has granted...
Product approvals
Kelun-Biotech’s Trastuzumab Botidotin Approved by NMPA for HER2-Positive Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced on October 17, 2025, that its Human...
Huadong Medicine Secures NMPA Approval for Relmapirazin Injection, Complementing MediBeacon TGFR Device
Huadong Medicine (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has granted marketing...
Sinclair’s MaiLi Precise Receives NMPA Acceptance Notice for Class III Device
Sinclair (Hangzhou) Medical Technology Co., Ltd., a wholly‑owned subsidiary of Huadong Medicine (SHE: 000963), announced...
UCB Biosciences Receives NMPA Marketing Authorization for Zilucoplan (Zilbrysq) in Adult Generalized Myasthenia Gravis
UCB S.A. (EBR: UCB), a global biopharmaceutical company, announced today that the National Medical Products...
GSK Receives China NMPA Approval for Shingrix in Immunocompromised Adults
GlaxoSmithKline (NYSE: GSK) announced today that the Chinese National Medical Products Administration (NMPA) has granted approval...
Arcutis Biotherapeutics Receives FDA Approval for ZORYVE (Roflumilast) Cream in Children 2‑5 Years with Atopic Dermatitis
Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), the U.S. partner of Huadong Medicine Co., Ltd. (SHE: 000963), announced today that...
Amoytop Biotech Secures NMPA Approval for Pegbinterferon Combination Therapy in Chronic Hepatitis B
Amoytop Biotech Co. Ltd. (SHA: 688278) announced today that the National Medical Products Administration (NMPA)...
Sichuan Kelun‑Biotech Wins NMPA Approval for Sacituzumab‑Tirumotecan in EGFR‑Mutant Lung Cancer
China‑listed Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the National Medical Products...
Boehringer Ingelheim Secures FDA Approval for Nerandomilast (JASCAYD) in Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim (BI) announced today that the U.S. Food and Drug Administration (FDA) has approved...
China’s NMPA Approves Mufemilast (Hemay005) — Hemei’s First Domestic PDE4 Inhibitor
The National Medical Products Administration (NMPA) announced that Jiangxi Hemei Pharmaceutical Co., Ltd. has received...
Acotec Scientific Receives FDA 510(k) Clearance for Endovenous Radiofrequency Ablation System
Acotec Scientific Holdings Limited (HKG: 6669) announced on October 7, 2025 that its Endovenous Radiofrequency Ablation System...
Mirxes Secures China’s First Blood‑Test Approval for Gastric‑Cancer Screening
Mirxes Holding Company Limited (HKG: 2629) announced that its flagship in‑vitro diagnostic (IVD) test, GASTROClear,...
Roche Secures FDA Approval for Tecentriq‑Lurbinectedin Combo in ES‑SCLC
Roche (SWX: ROG, OTCMKTS: RHHBY) announced today that the U.S. Food and Drug Administration (FDA)...
Walvax Biotech Wins Jordan FDA Approval for 13‑Valent Pneumococcal Vaccine
China‑based Walvax Biotechnology Co., Ltd. (SHE: 300142) has secured market approval from the Jordan Food...
Changchun GeneScience Secures China Approval for Long‑Acting FSH‑CTP Injection
China‑based Changchun GeneScience Pharmaceutical Co. Ltd. announced that its long‑acting recombinant human follicle‑stimulating hormone—CTP fusion...
Sinopharm Secures NMPA Approval for QuadrivalentHPV Vaccine
China’s Sinopharm Group Co., Ltd. (Chengdu Institute of Biological Products, a subsidiary of the China...
Eisai & Biogen Secure Leqembi China Maintenance Approval
Japanese drugmaker Eisai Co., Ltd. (TYO: 4523) and U.S. biopharma Biogen Inc. (NASDAQ: BIIB) announced...
MicroTech Medical Secures NMPA Approval for Equil Patch Insulin Pump in Children and Adolescents
MicroTech Medical (Hangzhou) Co., Ltd. (HKG: 2235) announced that China’s National Medical Products Administration (NMPA)...
Eisai and Biogen Secure Australian TGA Approval for Lecanemab in Early Alzheimer’s Disease
Eisai (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced today that the Australian Therapeutic Goods...