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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
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Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
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Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
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Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its combination therapy of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65 mg capsules. This innovative two-component therapy is specifically indicated for adults diagnosed with…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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Neusoft Medical’s NeuRT Aurora Receives NMPA Approval for Advanced Radiotherapy Platform
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Neusoft Medical Systems Co., Ltd, a leading player in the medical technology sector, has announced that its radiotherapy unit, Neusoft Ruizhi Radiotherapy Technology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for the high-end medical linear accelerator, NeuRT Aurora intelligent radiotherapy platform. This approval marks…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
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Everest Medicines’ Xerava Receives Marketing Approval from TFDA for cIAI Treatment
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Everest Medicines (HKG: 1952) has announced that it has received marketing approval for its antibiotic Xerava (eravacycline) from the Taiwan Food and Drug Administration (TFDA). This approval grants the drug permission to be used in the treatment of complicated intra-abdominal infections (cIAI) in Taiwan, expanding the drug’s reach in the…
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Sino Medical Sciences Receives Turkish Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received market approval for its HT Supreme drug-eluting stent system from the Ministry of Health in Turkey. This approval marks a significant expansion of the product’s reach and is set to benefit…
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EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that…
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Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
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Acotec Scientific Holdings Receives Japanese Marketing Approval for Peripheral Support Catheter Vericor
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the Ministry of Health, Labour and Welfare of Japan for its peripheral support catheter, Vericor. This approval allows the product to be used in conjunction with a guide wire to…
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Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
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France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for…
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Sansure Biotech Secures CE Mark for 60 Molecular Diagnostic Products, Including Procalcitonin Assay Kit
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Sansure Biotech Inc., a leading molecular diagnostics specialist based in China (SHA: 688289), has announced that it has received CE marks for 60 of its products, including a procalcitonin assay kit that utilizes chemiluminescent immunoassay technology. This significant milestone underscores the company’s commitment to expanding its global footprint and enhancing…
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Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China. Phase III…
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Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
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US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
