Bayer/Regeneron’s Eylea HD Wins Japan Approval for RVO – Third Indication Nod with Extended Dosing Demonstrates 3 Fewer Injections
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Eylea HD (aflibercept) injection 8...
Product approvals
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...
RemeGen Secures Fourth NMPA Approval for Disitamab Vedotin – HER2‑Low Breast Cancer with Liver Metastases Indication Expands ADC Franchise
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) announced NMPA approval for a new indication of...
Grand Pharma Wins NMPA Approval for GPN01768 – First Targeted Therapy for Demodex Blepharitis in China
Grand Pharmaceutical Group (HKG: 0512) announced that its licensed‑in global innovative ophthalmic drug GPN01768 [TP‑03,...
GSK Wins FDA Approval for Lynavoy – First US Treatment for PBC Cholestatic Pruritus as Alfasigma Acquisition Nears Close
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has...
Hengrui Pharma’s HER2 ADC SHR-A1811 Wins NMPA Approval for Breast Cancer – Second Indication Expands Trastuzumab Rezetecan Franchise
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its self-developed Category 1...
3SBio Wins NMPA Approval for SSS06 – Extended‑Half‑Life Erythropoietin Enables Biweekly Dosing in Dialysis Anemia
3SBio Inc. (HKG: 1530) announced that China’s National Medical Products Administration (NMPA) has approved SSS06,...
Belief BioMed Secures Macao Approval for BBM‑H901 – China’s First Hemophilia B Gene Therapy Expands to Greater China with Takeda
Belief BioMed announced marketing approval from the Pharmaceutical Administration Bureau of Macao Special Administrative Region...
Novo Nordisk Wins FDA Approval for Wegovy HD 7.2 mg – Higher‑Dose Semaglutide Delivers 21% Weight Loss in STEP UP Trial
Novo Nordisk A/S (NYSE: NVO) announced FDA approval of Wegovy HD (semaglutide) 7.2 mg injection,...
Super Vision Technology Wins NMPA Approval for Ocular Neurostimulator – First-in-Class Implantable Device Treats Congenital Nystagmus
Super Vision Technology, Inc. announced National Medical Products Administration (NMPA) approval for its implantable ocular...
AstraZeneca Secures EU Approval for Imfinzi in Gastric Cancer – Perioperative Regimen Cuts Death Risk 22% in MATTERHORN Trial
AstraZeneca PLC (NASDAQ: AZN) announced European Union marketing approval for Imfinzi (durvalumab) in combination with...
Bio-heart Bio Expands Iberis RDN Registration to Thailand – World’s Only Dual‑Access Renal Denervation System
Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced Thailand regulatory registration of its Iberis...
Peijia Medical Secures First FDA 510(k) Clearance for DCwire Micro Guidewire – US Market Entry Milestone
Peijia Medical Ltd (HKG: 9996) announced that its DCwire micro guidewire has received 510(k) clearance...
Basecare Medical Secures NMPA Approval for First Domestic‑Platform PGT‑A Kit – Milestone for China IVF Genetic Testing Independence
Suzhou Basecare Medical Corporation Limited (HKG: 2170) announced that its Embryo Pre‑implantation Chromosomal Aneuploidy Testing...
CMS Secures NMPA Approval for Desidustat – First Domestic HIF-PHI for Non-Dialysis CKD Anemia Enters China Market
China Medical System Holdings (CMS; HKG: 0867) announced marketing approval from China’s National Medical Products...
3SBio Wins NMPA Approval for Eltrombopag Generic – TPO-RA Copycat Targets Novartis’ Revolade in China ITP/SAA Market
3SBio Inc. (HKG: 1530) announced NMPA marketing approval for its generic version of Novartis’ Revolade...
Novartis’ Cosentyx Wins FDA Pediatric Approval – Only IL-17A Inhibitor for Hidradenitis Suppurativa in Adolescents 12+
Novartis (NYSE: NVS) announced that Cosentyx (secukinumab) received U.S. FDA approval for treating pediatric patients aged...
GSK’s Arexvy Wins FDA Label Expansion – RSV Vaccine Now Covers High-Risk Adults Aged 18-49
GlaxoSmithKline (GSK, NYSE: GSK) announced FDA approval for a label expansion of its adjuvanted respiratory...
China NMPA Approves World’s First Invasive BCI Medical Device – Brain-Computer Interface Hand Motor System Targets Spinal Cord Injury Patients
China’s National Medical Products Administration (NMPA) granted registration approval for the “Implantable Brain-Computer Interface Hand...
J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved a...