FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN)...
Product approvals
North China Pharmaceutical’s Ormutivimab Approved for Pediatric Use in China
North China Pharmaceutical Group Corporation (SHA: 600812) has announced that it has received approval from...
Chunlizhengda’s Handheld Orthopedic Robot Approved by China’s NMPA
Beijing Chunlizhengda Medical Instruments Co., Ltd (HKG: 1858, SHA: 688236) has received marketing approval from...
ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals...
BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China,...
Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced...
Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China,...
Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug...
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,...
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...