Company Product Description Indication Status Date
Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. Tevimbra (tislelizumab) Humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages Unresectable, locally advanced or metastatic esophageal squamous cell carcinoma European Commission approved as monotherapy for the treatment of adult patients 9/20/2023
Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. Tevimbra (tislelizumab) Humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages Unresectable, locally advanced or metastatic esophageal squamous cell carcinoma U.S. FDA accepted for review a BLA 9/20/2023
Daiichi Sankyo Co. Ltd., of Tokyo Vanflyta (quizartinib) FLT3 inhibitor Acute myeloid leukemia FLT3-ITD positive EMA's CHMP recommended for approval in combination with cytarabine + anthracycline induction and standard cytarabine consolidation chemotherapy 9/19/2023
Dizal Pharmaceutical Co. Ltd., of Shanghai Golidocitinib (DZD-4205) Janus kinase 1 (JAK1) inhibitor Relapsed or refractory peripheral T-cell lymphoma China's NMPA granted priority review status to the NDA 9/22/2023
Everest Medicines Ltd., of Shanghai Cefepime-taniborbactam Intravenous (IV) beta-lactam/beta-lactamase inhibitor antibiotics Complicated urinary tract infections China's NMPA recommended priority review NDA; PDUFA target action date for priority review NDA in U.S. is Feb. 22, 2024 9/21/2023
Hepagene Therapeutics Inc., of Nanjing, China HPG-7233 Agonist of thyroid hormone receptor beta (THR-β) Nonalcoholic steatohepatitis (NASH) and dyslipidemia U.S. FDA cleared IND 9/21/2023
Mabwell Bioscience Co. Ltd., of Shanghai 9MW-3011 Monoclonal antibody Polycythemia vera U.S. FDA granted fast track designation 9/25/2023
Mesoblast Ltd., of Melbourne, Australia Ryoncil (remestemcel-L) Mesenchymal stem cell therapy Pediatric and adult steroid-refractory graft-vs.-host disease Completed type A meeting with the U.S. FDA; lack of potency assay in pediatrics; adequate study for the purpose of demonstrating substantial evidence of effectiveness required for a marketing approval 9/22/2023
Micurx Pharmaceutical Co. Ltd., of Shanghai Contezolid and contezolid acefosamil Oxazolidinone agent Diabetic foot infection U.S. FDA granted Qualified Infectious Disease Product (QIDP) and the fast track designation under the Generating Antibiotic Incentives Now (GAIN) Act 9/25/2023
Otsuka Pharmaceuticals Co. Ltd., of Tokyo, and Astex Pharmaceuticals Inc., of Cambridge, U.K. Inaqovi Fixed-dose combination oral decitabine and cedazuridine Acute myeloid leukaemia European Commission approved as monotherapy 9/20/2023
Sandoz Inc., of Basel, Switzerland, and Eirgenix Inc., of Taipei, Taiwan Biosimilar trastuzumab HER2 inhibitor HER2-positive breast cancer and metastatic gastric cancers EMA's CHMP adopted a positive opinion recommending marketing authorization 150-mg for intravenous route 9/19/2023
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan TAK-721 (budesonide oral suspension) Glucocorticoid receptor agonist Eosinophilic esophagitis U.S. FDA accepted for review its NDA resubmission 9/21/2023

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.