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...
Product approvals
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...
Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy
Burning Rock Ltd. (NASDAQ: BNR), a China‑based medical‑technology company, announced that its OncoGuide OncoScreen Plus CDx...
Stealth BioTherapeutics Receives FDA Accelerated Approval for Forzinity in Barth Syndrome
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Stealth BioTherapeutics’ Forzinity (elamipretide)...
Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...
Henlius Organon Secure EU Marketing Approval for BILDYOS and BILPREVDA Denosumab Biosimilars
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission...
Innovent Secures 2nd NMPA Approval for Mazdutide – First Dual GLP‑1/GCGR Therapy for Type 2 Diabetes
Innovent Biologics Ltd. (HKG: 1801) announced that its mazdutide injection (IBI362) has received its second...
Novo Nordisk Rybelsus Gains Cardio Benefit from SOUL Trial
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products...
Sino Biopharmaceutical Secures NMPA Approval for Degarelix Generic in China
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Haisco Pharma Secures NMPA Approval for Anrikefon in Hemodialysis‑Related Pruritus
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the China National Medical Products Administration...
Fovinaciclib CDK4/6 Breaks Ground in Breast‑Cancer Therapy
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its subsidiary Avanc...