AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health,...
Product approvals
Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China,...
Takeda Gains MHLW Approval for Adzynma, Targeting Rare Blood Disorder cTTP
Takeda Pharmaceutical Company (TYO: 4502) has secured regulatory approval from Japan’s Ministry of Health, Labour...
Acotec Scientific Receives NMPA Approval for Innovative Cardiovascular Devices
Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has...
Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with...
MSD’s Winrevair Approved by FDA as First Activin Signaling Inhibitor for Pulmonary Arterial Hypertension
The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE:...
FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE:...
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,...
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...