Boehringer, Eli Lilly’s Jardiance Wins NMPA Approval for Heart Failure with Preserved Ejection Fraction
Boehringer Ingelheim and Eli Lilly (NYSE: LLY) announced that China’s National Medical Products Administration (NMPA)...
Product approvals
Merck’s Gardasil 9-Valent HPV Vaccine Approved for Expanded Age Range in China
US-based Merck Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration...
Sinocelltech’s Ripertamab Wins NMPA Approval for DLBCL Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the...
Roche’s Rozlytrek Wins NMPA Approval for ROS1+ NSCLC Treatment
Swiss pharmaceutical giant Roche’s China unit announced that it has received market approval from the...
Zelgen Biopharmaceuticals’ Donafenib Receives NMPA Approval for Thyroid Cancer
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that the supplementary New Drug Application...
GeneoDx Biotech’s Cervical Cancer Screening Kit Wins NMPA Approval
Shanghai GeneoDx Biotech Co., Ltd, a medical diagnosis unit of Sinopharm, has announced that it...
NMPA Approves BioFire Diagnostics’ Encephalitis/Meningitis Detection Kit
The National Medical Products Administration (NMPA) website indicates that BioFire Diagnostics LLC’s encephalitis/meningitis multiple pathogen...
Wision A.I.’s Polyp Detection Software Secures NMPA Approval for Colonoscopy Use
The National Medical Products Administration (NMPA) has approved China-based Wision A.I.’s intestinal polyp electronic colonoscopy...
Ethicon’s Hemostatic Granules Win NMPA Approval for Endoscopic Surgery Use
The National Medical Products Administration (NMPA) has granted marketing approval to U.S. medical device firm...
Eli Lilly’s Taltz Wins Second NMPA Approval for Ankylosing Spondylitis
U.S. pharmaceutical giant Eli Lilly announced it has received a second marketing approval from the...
Roche’s Rozlytrek Wins NMPA Approval for NTRK Fusion Gene-Positive Tumors
Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical...
AbbVie’s Allergan Aesthetics CoolAdvantage Applicator Wins NMPA Approval
US-based AbbVie’s Allergan Aesthetics announced that it has received marketing approval from the National Medical...
Henlius Biotech’s Hanquyou Approved in Australia for HER2-Positive Cancers
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received marketing approval from Australia’s...
NMPA Approves Genuine Biotech’s Azvudine for COVID-19, Fosun Pharma Inks Licensing Deal
China’s National Medical Products Administration (NMPA) has conditionally approved HeNan Genuine Biotech Co., Ltd’s azvudine...
Lepu Biopharma’s Pucotenlimab Receives Conditional NMPA Approval for MSI-H/dMMR Tumors
The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co.,...
CStone Pharmaceuticals’ Gavreto Wins Hong Kong Approval for RET Fusion NSCLC
CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval...
NMPA Approves RocketHeart’s LV Assist System and Our United Group’s Radiation Therapy Device
The National Medical Products Administration (NMPA) has approved marketing for two innovative medical devices: RocketHeart’s...
BeiGene’s Tislelizumab Faces FDA Delay Due to Inspection Hurdles
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision...
Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products...
Venus Medtech’s Transcatheter Prosthetic Pulmonary Valve Approved by NMPA
The National Medical Products Administration (NMPA) has approved Venus Medtech (Hangzhou) Inc’s (HKG: 2500) transcatheter...