Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine,...
Product approvals
Jiangsu BioPerfectus’ Dengue Detection Kit Gains NMPA Approval for Commercialization
Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading in vitro diagnostic (IVD) product manufacturer...
China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction
Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle,...
MicroPort MedBot’s Toumai Robot Gets EU Green Light for Broad Surgical Applications
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that its Toumai endoscopic surgery...
Blue Sail Medical’s New Catheter Receives NMPA Approval for Complex Coronary Lesion Treatment
China’s Blue Sail Medical Co., Ltd (SHE: 002382) has received marketing approval from the National...
Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in...
Andon Health’s Triplex Virus Test Kit Receives US FDA Emergency Use Authorization
Andon Health Co., Ltd (SHE: 002432), a leading healthcare company based in China, has announced...
Medtronic’s RDN System Symplicity Spyral Earns First-Ever NMPA Approval
Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal...
Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval...
Wondfo Biotech’s WELLlife Test Kit Receives FDA Nod for Home Use in the US
Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a leading biotechnology company based in China, has...
United Imaging’s uMR Jupiter 5T Becomes First Ultra-High Frequency MRI System to Gain FDA Approval
Shanghai-based medical equipment manufacturer United Imaging Healthcare (UIH, SHA: 688271) has announced that it has...
BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has...
China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
Shenzhen Chipscreen Biosciences Co., Ltd, a biopharmaceutical company based in China, announced that it has...
Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration...
EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration...
Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE)...
Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan...
US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food...
Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS)...
European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam +...