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Abbott Laboratories’ Volt PFA System Receives EU CE Mark for Atrial Fibrillation Treatment
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US-based Abbott Laboratories (NYSE: ABT) has announced the receipt of the CE mark in the European Union (EU) for its Volt PFA System, a novel therapy for patients with atrial fibrillation (AFib). This approval marks a significant advancement in treatment options for AFib, particularly for those with complex conditions. Technology…
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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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NMPA Approves Qingfeng’s Suraxavir Marboxil for Influenza A and B Treatment
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China’s National Medical Products Administration (NMPA) has approved suraxavir marboxil, a Category 1 drug developed by Qingfeng Pharmaceutical Group Co. Ltd’s subsidiary Jiangxi Kerui Pharmaceutical Co., Ltd, for the treatment of influenza A and B. The drug is intended for adolescents aged 12 and above as well as adults with…
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YiChang HEC’s Yiqibuvir Approved by NMPA for Chronic HCV Infection
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd. (HKG: 1558) announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug yiqibuvir. The non-structural protein 5B (NS5B) inhibitor is approved for use in combination with netanasvir in adult chronic hepatitis C virus (HCV) infections of genotypes…
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Merck, Sharp & Dohme’s Capvaxive Approved by European Commission for Pneumococcal Prevention
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced the European Commission (EC) approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is approved to prevent invasive disease and pneumonia caused by 21 different Streptococcus pneumoniae serotypes in adults: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,…
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Shanghai Junshi Biosciences’ Loqtorzi Approved in Singapore for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Singapore Health Sciences Authority (HSA) for its Loqtorzi (toripalimab). The anti-PD-1 monoclonal antibody (mAb) is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for recurrent, not amenable to surgery…
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AstraZeneca’s Calquence Approved by NMPA for CLL/SLL Treatment
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UK pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving another indication approval from China’s National Medical Products Administration (NMPA) for its Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as a monotherapy. This marks the third…
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Shanghai ZJ Bio-Tech’s HCV Nucleic Acid Test Kit Receives NMPA Approval
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China-based molecular diagnostic reagent specialist Shanghai Liferiver Bio-Tech Co., Ltd (SHA: 688317) has announced receiving Category III medical device license from the National Medical Products Administration (NMPA) for its hepatitis C virus (HCV) nucleic acid test kit (fluorescent PCR method). This product is designed for the quantitative detection of HCV…
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Sichuan Huiyu Pharmaceutical Wins Marketing Approvals in Italy, Portugal, Saudi Arabia
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China-based Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553) has announced its its subsidiaries Seacross Pharma (Europe) and Seacross Pharmaceuticals Ltd. receiving a series of marketing approvals for its products in Italy, Portugal, and Saudi Arabia. The approved products include valproate concentrated solution, zoledronic acid, teicoplanin, and plerixafor. Valproate Concentrated SolutionValproate,…
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GSK’s Blujepa Approved by FDA for Uncomplicated Urinary Tract Infections
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its drug Blujepa (gepotidacin). The approval allows the use of Blujepa in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract…
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Jenscare Scientific’s Ken Valve Receives NMPA Marketing Approval
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Jenscare Scientific Co., Ltd (HKG: 9877), a Ningbo-based structural heart disease device maker, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its transcatheter artificial aortic valve system Ken Valve. The company is now preparing for the commercialization of the product. Product Design and AdvantagesThe in-house…
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Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or…
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Broncus Medical’s BroncQCT Approved by Zhejiang Administration for China Market Entry
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Broncus Medical Inc., a provider of precision intervention solutions for lung diseases with operations in Shanghai, Hangzhou (China), and San Jose, Seattle (United States), has received approval from the Zhejiang Medical Products Administration to market its BroncQCT lung image processing software in China. Software FunctionalityBroncQCT processes CT images through advanced…
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Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication for its PD-1 inhibitor Loqtorzi (toripalimab). The drug is now approved for use in combination with bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC),…
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HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received…
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Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
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US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the US Food and Drug Administration (FDA) to market its Tremfya (guselkumab) as a treatment for moderately to severely active Crohn’s disease (CD). This IL-23 inhibitor now offers both subcutaneous (SC) and intravenous (IV) induction options…
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Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
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Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G). This marks the first and only approved therapy specifically targeting this rare kidney disease, which is characterized by a poor…
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Telix Pharmaceuticals Gains Brazilian Approval for Prostate Cancer Diagnostic Agent TLX591-CDx
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer. This approval allows the drug to be used in positron emission tomography (PET) for detecting prostate-specific membrane…
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AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Clinical Need and Approval SignificanceSCLC is a highly…
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Lifetech Scientific’s Aortic Stent System Approved by China’s NMPA
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China-based Lifetech Scientific Corporation (HKG: 1302) announced receiving market approval from the National Medical Products Administration (NMPA) for its aortic branch reconstruction covered stent system (chimney), co-developed with Fuwai Hospital. This innovative product offers a novel treatment option for patients with arch lesions. Product InnovationThe aortic branch covered stent system…
