www.bioworld.com/articles/702407-regulatory-actions-for-oct-24-2023
Regulatory actions for Oct. 24, 2023
Oct. 24, 2023
| Company | Product | Description | Indication | Status | Date |
| Astrazeneca plc, of London, and Daiichi Sankyo Co. Ltd., of Tokyo | Enhertu (trastuzumab deruxtecan) | HER2-directed antibody-drug conjugate | Advanced non-small-cell lung cancer | European Commission approved the drug | 10/25/2023 |
| Bioray Pharmaceutical Co. Ltd., of Shanghai | BR-105 | Monoclonal antibody targeting SIRPα | Cancer | U.S. FDA cleared the IND for a phase I study | 10/25/2023 |
| Biosyngen Pte Ltd., of Singapore | BST-02 | Adoptive immune cell therapy | Liver cancer | U.S. FDA approved IND | 10/27/2023 |
| Calliditas Therapeutics AB, of Stockholm, and Everest Medicines Ltd., of Shanghai | Nefecon | Oral, delayed release formulation of budesonide | Primary immunoglobulin A nephropathy | Pharmaceutical Administration Bureau of the Macau Special Administrative Region approved NDA in China | 10/30/2023 |
| Genexine Inc., of Seoul, South Korea, and PT Kalbe Farma Tbk, of Jakarta, Indonesia | Efepoetin alfa | Long-acting erythropoietin | Chronic kidney disease induced anemia | Indonesian Food and Drug Authority approved the drug | 10/25/2023 |
| Life Molecular Imaging GmbH, of Berlin, and Sinotau Pharmaceutical Group, of Beijing | Neuraceq (florbetaben F-18 injection) | Radiopharmaceutical imaging agent targeting β-amyloid | Alzheimer’s disease | National Medical Products Administration in China approved the imaging agent | 10/25/2023 |
| Samsung Bioepis Co. Ltd., of Incheon, Korea | Byooviz (ranibizumab-nuna) | Biosimilar product interchangeable with Lucentis (ranibizumab); anti-VEGF | Wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization | U.S. FDA approved the supplemental BLA | 10/26/2023 |
| Sumitomo Pharma Canada Inc., a unit of Sumitomo Pharma Co. Ltd., of Osaka, Japan | Orgovyx (relugolix) | Gonadotropin-releasing hormone receptor antagonist | Advanced prostate cancer | Health Canada approved the drug | 10/25/2023 |
Notes The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found. For more information about individual companies and/or products, see Cortellis.
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