Recently, AbbVie announced that the National Medical Products Administration (NMPA) of China has approved two new indications for its JAK inhibitor, upadacitinib extended-release tablets.
The US FDA has approved Biosyngen's BST02 for clinical trials. This cutting-edge TIL liver cancer therapy is a pioneer in cellular and gene therapy and is the first universal liver cancer TIL treatment to progress to the clinical stage.
Genentech has communicated that the FDA has given approval for Vabysmo®(faricimab-svoa) to be used in treating macular edema that occurs after retinal vein occlusion.
Tenaya Therapeutics, a clinical-phase biotech firm focusing on heart disease treatments, announced today they've received FDA approval for their IND application to begin clinical trials for TN-401.
Mustang Bio, Inc., a biopharmaceutical firm conducting clinical trials and developing cell and gene therapies for difficult cancers and rare genetic diseases, announced FDA approval of their IND application for MB-109.
Recently, CSPC Pharmaceutical announced that its independently developed bispecific antibody targeting Claudin6/CD137, NBL-028, has received approval from the National Medical Products Administration (NMPA) in China for clinical trial applications.
Recently, Biogen announced positive results from the Phase 1b trial of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau protein for the treatment of mild Alzheimer's Disease (AD).
Recently, Immatics announced that its T cell receptor T cell (TCR-T) therapy IMA203 under research has been granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the Center for Biologics Evaluation and Research (CBER) of the U.S. FDA.
On Oct 24, 2023, China's CDE announced that Purunao Biotechnology, a subsidiary of Anshi Biotechnology, applied to list a new indication for the Class 1 new drug Vebreltinib on their official website.
On Oct 25, 2023, Huadong Medicine's subsidiary, Hangzhou Zhongmeihuadong Pharmaceutical, was granted a "Notice of Acceptance" by the NMPA for their marketing application for Mirvetuximab Soravtansine Injection (IMGN853, HDM2002), co-developed with ImmunoGen.
On Oct 25, 2023, Celltrion reported US FDA approval of Zymfentra (infliximab) for continued treatment of adult ulcerative colitis (UC) and Crohn's disease (CD) after intravenous infliximab treatment.
Yasheng Pharmaceutical presented updated clinical data for APG-1252 and Osimertinib to treat EGFR mutation lung cancer patients at the 2023 ESMO meeting on October 23, 2023.