AbbVie’s Emrelis Granted FDA Accelerated Approval for NSCLC with High c-MET Overexpression
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to AbbVie’s (NYSE: ABBV)...
Product approvals
Novartis’ Kisqali Receives NMPA Approval for High-Risk Early Breast Cancer
Switzerland-based Novartis (NYSE: NVS) announced this week that it has received another indication approval from...
Roche’s VENTANA MET (SP44) RxDx Assay Gains FDA Approval for NSQ-NSCLC Patients
Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the FDA has approved the VENTANA®...
Sinovac Biotech Gains Hong Kong Approval for Influenza Vaccines
China-based Sinovac Biotech Ltd (NASDAQ: SVA) announced that it has received marketing approvals from the...
United Imaging Healthcare Gains FDA Approval for uAngio AVIVA Interventional X-ray System
China-based United Imaging Healthcare (UIH, SHA: 688271) announced that it has received marketing approval from...
AstraZeneca’s Trixeo Aerosphere Wins UK Approval for COPD
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced this week that it has received marketing...
MicroPort’s Talos Stent Gains Marketing Approval in Argentina
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) announced that it has received marketing approval...
Hansoh Pharma’s Ameile Wins Fourth NMPA Approval for NSCLC Treatment
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its epidermal growth factor receptor...
UCB Gets Japanese Approval for New Administration Routes of Rystiggo in gMG
Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from Japan’s Pharmaceuticals and...
RemeGen’s Disitamab Vedotin Receives NMPA Approval for HER2+ Breast Cancer with Liver Metastasis
China-based biopharma RemeGen Ltd (HKG: 9995) announced that the National Medical Products Administration (NMPA) has...
Sino Medical Sciences Gains Mexican Approval for Coronary Balloon Catheters
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval...
J&J’s Tremfya Approved for Ulcerative Colitis in China
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that it has received marketing approval...
Pfizer’s Zavicefta Approved by China’s NMPA for Severe Infections in All Ages
US-based pharmaceutical giant Pfizer (NYSE: PFE) announced that it has received market approval from China’s...
Amgen’s Tepezza Approved in UK for Thyroid Eye Disease Treatment
US biotech Amgen (NASDAQ: AMGN) announced that the UK’s Medicines and Healthcare products Regulatory Agency...
European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya...
AstraZeneca’s Calquence Gains EU Approval for Mantle Cell Lymphoma
UK-based pharmaceutical major AstraZeneca (AZ; NASDAQ: AZN) announced receiving another indication approval in the European...
Shuangcheng Pharma’s Generic Bivalirudin Approved by Australia’s TGA
China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) announced that the market filing for its...
Everest Medicines’ Nefecon Receives Full Approval from NMPA for IgAN Treatment
China-based Everest Medicines (HKG: 1952) announced that the National Medical Products Administration (NMPA) has converted...
Johnson & Johnson’s Imaavy Gains FDA Approval for Generalized Myasthenia Gravis
US giant Johnson & Johnson (J&J, NYSE: JNJ) unveiled a market approval in the United...
AbbVie’s Rinvoq Gains FDA Approval for Giant Cell Arteritis
US-based pharma giant AbbVie (NYSE: ABBV) announced regulatory approval from the US Food and Drug...