Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices,...
Product approvals
Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s...
EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
FibroGen’s Roxadustat Approved in Macau for Chronic Kidney Disease-Related Anemia
FibroGen Inc. (NASDAQ: FGEN), a biopharmaceutical company based in the US, has announced that it...
Yifan Pharmaceutical’s F-627 Approved by European Commission for Marketing in EU
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that its subsidiary...
FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s...
Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment
Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore...
Sino Medical Sciences Secures South Korean Approvals for Three Cardiovascular Devices
Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced...
BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted...
Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s...
KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA)...
Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has...
Madrigal Pharmaceuticals’ Rezdiffra Earns FDA Accelerated Approval for NASH in Adults
The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’...
European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent...
ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched...
FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to...
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY)...
China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has...
Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from...