Legend Biotech’s Carvykti Approved in Japan for Relapsed Multiple Myeloma
China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan’s Ministry of Health, Labour and...
Product approvals
MicroPort CardioFlow’s Alwide Plus Balloon Catheter Approved in Colombia
MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG:...
Sino Medical Sciences Gains Approval for Drug-Eluting Stent System
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received market...
China’s First Proton Therapy System Approved by NMPA
The National Medical Products Administration (NMPA) has approved the proton therapy system developed by Shanghai...
Humanwell’s Generic Clobazam Approved for Lennox-Gastaut Syndrome in China
China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version of Sanofi’s clobazam (trade name: Frisium) has...
AstraZeneca and Merck’s Lynparza Receives New Approval in China
UK-based AstraZeneca (NASDAQ: AZN) and US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) have announced...
Junshi Biosciences’ Tuoyi Approved for First-Line NSCLC Treatment in China
China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi...
BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication...
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...
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...