Lepu Medtech Receives Approval for Innovative Peripheral Cutting Balloon
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced...
Product approvals
Huahai Pharmaceutical Gains FDA Approval for Generic Fingolimod
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
Hotgen Biotech Receives UK Approvals for Monkeypox and COVID-19 Antigen Detection Kits
Shanghai-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced significant regulatory milestones in the United...
CanSino, Livzon Win China EUAs for COVID-19 Booster Vaccines
China-based vaccine makers CanSino Biologics (HKG: 6185) and Livzon Pharmaceutical Group Inc. (HKG: 1513) have...
AstraZeneca’s Farxiga Wins China Approval for Chronic Kidney Disease
UK pharma giant AstraZeneca (AZ, NASDAQ: AZN) announced a new approval for Farxiga (dapagliflozin), its...
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)...
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.,...