FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
The US Food and Drug Administration (FDA) has declined to approve a filing from Merck,...
Product approvals
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced...
Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy...
Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from...
FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have...
Sanofi’s Rezurock Secures Marketing Approval in China for Chronic Graft-vs-Host Disease
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s...
MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck,...
MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market...
Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two...
Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board...
Cryofocus Medtech Receives NMPA Approval for Complete Cardiac Cryoablation System
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced...
Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
Zylox-Tonbridge Medical Technology (HKG: 2190), a developer of nerve and peripheral vascular interventional devices based...
Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National...
AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval...
Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the...
Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it...
Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and...
Sinocare Inc’s Blood Glucose Monitoring System Earns US FDA Approval
Sinocare Inc (SHE: 300298), a Chinese medical device company, has announced that it has received...