Mabwell (Shanghai) Bioscience Co. Ltd. announced that its Cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC), 7MW-4911, has received IND clearance to initiate clinical trials from both the U.S. FDA and China's National Medical Products Administration (NMPA).
The U.S. FDA has cleared Actio Biosciences Inc.’s IND application and granted fast track designation to ABS-1230, an expected first-in-class, orally administered small-molecule KCNT1 inhibitor, for the treatment of KCNT1-related epilepsy.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
The U.S. FDA has cleared Zymeworks Inc.’s IND application for ZW-251, a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating the company’s proprietary topoisomerase 1 (TOPO1) inhibitor payload, ZD-06519, for the treatment of hepatocellular carcinoma (HCC).
The U.S. FDA has cleared Genetic Leap’s IND application for GL-IL2-138, a small-molecule RNA drug that modulates natural IL-2, allowing for downregulating or upregulating of the immune system to fight diseases.
The U.S. FDA has cleared Aavantgarde Bio Srl’s IND application for AAVB-039, the company’s gene therapy program for Stargardt disease, the most common inherited form of macular degeneration.
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
Eluciderm Inc. has received clearance from the U.S. FDA for its IND to conduct a phase I/IIa open-label study evaluating the safety and efficacy of ELU-42, a topical spray-on solution for open wound healing, in patients with diabetic foot ulcers (DFUs).
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