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)...
Product approvals
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...
Shenzhen Kangtai Receives NMPA Approval for Sabin‑Strain Inactivated Polio Vaccine
Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) announced today that the China National Medical...
Novartis Secures Tabrecta Approval in China for METex14 NSCLC
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its MET‑receptor tyrosine kinase inhibitor Tabrecta (capmatinib...
Johnson & Johnson Secures FDA Approval for INLEXZO, a Ground‑breaking Intravesical System for Bladder Cancer
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug...
Novartis Expands Iptacopan Approval to IgA Nephropathy in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its first‑in‑class oral inhibitor Iptacopan (Fabhalta) has...
DaAn Gene Secures NMPA Approval for First HIVDNA Diagnostic Kit
China‑based DaAn Gene Co., Ltd. (SHE: 002030), a research arm of Sun Yat‑sen University, announced that...
Grand Pharma Secures CE Mark for SIR‑Spheres Y‑90, Expanding Liver‑Cancer Treatment Portfolio
Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR‑Spheres Y‑90 resin microsphere injection (brand name:...
InnoCare Pharma Secures Singapore HSA Approval for Orelabrutinib in Relapsed MZL
Shanghai‑based InnoCare Pharma (HKG: 9969, SHA: 688428) announced on September 8, 2025 that its Bruton’s tyrosine kinase...
Takeda Secures FDA Approval for VONVENDI’s Expanded Use in Adult and Pediatric VWD
Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) today confirmed that the U.S. Food and Drug...
Innovent’s Xinbimin IGF‑1R Antibody Approved in Macau
China-based Innovent Biologics Inc. (HKG: 1801) announced that the Macau Special Administrative Region drug authority...