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Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
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Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
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European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
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The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
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Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it has received marketing approval from the Thailand Food and Drug Administration (TFDA) for its enoxaparin sodium for injection. The approved specifications include 0.2ml (20mg) and 0.4ml (40mg), indicated for the prevention of venous thromboembolic diseases,…
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Sino Medical Secures Approval for Innovative Drug-Coated Stent System Targeting Intracranial Stenosis
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced that it has received marketing approval from the Center for Medical Device Evaluation for its innovative self-expanding intracranial drug-coated stent system. This approval was granted through the special review channel, recognizing the device’s potential to treat intracranial atherosclerotic…
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Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
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Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
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Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China, has announced that it has received marketing approval from New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) for its enoxaparin sodium injection, which will be marketed under the trade name Exarane. Enoxaparin sodium injection…
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Takeda Gains MHLW Approval for Adzynma, Targeting Rare Blood Disorder cTTP
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Takeda Pharmaceutical Company (TYO: 4502) has secured regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its enzyme replacement therapy, Adzynma (apadamtase alfa), to treat congenital thrombotic thrombocytopenic purpura (cTTP) in patients aged 12 and older. cTTP is a rare and potentially life-threatening blood clotting disorder resulting…
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Acotec Scientific Receives NMPA Approval for Innovative Cardiovascular Devices
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for two of its innovative products: the coronary hypertension balloon dilation catheter wing extension and the microcatheter Vericor-RS. The coronary…
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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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MSD’s Winrevair Approved by FDA as First Activin Signaling Inhibitor for Pulmonary Arterial Hypertension
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The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation…
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FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
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This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
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Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has secured marketing approval from the National Medical Products Administration (NMPA) for its flow diverter (FD). This device represents a significant advancement in the treatment of intracranial aneurysms, particularly large and giant aneurysms. Notably, this…
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Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment…
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Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
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Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
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EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Novartis’s (NYSE: NVS) Factor B inhibitor Fabhalta (iptacopan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults with hemolytic anemia. The European Commission (EC) is anticipated to make a…
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FibroGen’s Roxadustat Approved in Macau for Chronic Kidney Disease-Related Anemia
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FibroGen Inc. (NASDAQ: FGEN), a biopharmaceutical company based in the US, has announced that it has received marketing approval in Macau for its drug roxadustat. The drug is indicated for the treatment of anemia caused by chronic kidney disease (CKD), encompassing both dialysis and non-dialysis patients. Roxadustat, an oral hypoxia-inducible…
