China's Leads Biolabs Wins FDA Nod to Begin First-in-Human Trial of Novel Autoimmune Therapy
The US Food and Drug Administration (FDA) has approved Leads Biolabs’ first-in-human Investigational New Drug (IND) application for LBL-047, a novel therapeutic candidate for the treatment of autoimmune diseases such as systemic lupus erythematosus, dermatomyositis, IgA nephropathy and Sjögren's syndrome.
Investigational New Drug (IND) Application | 22/09/2025 | By Dineshwori | 276
Iksuda Therapeutics Secures FDA IND Clearance for IKS014
Iksuda Therapeutics has received FDA clearance for its IND application for IKS014, a HER2-targeting antibody drug conjugate, paving the way for US site participation in its ongoing Phase 1 trial for advanced HER2-positive solid tumours.
Investigational New Drug (IND) Application | 02/07/2025 | By Mrinmoy Dey | 175
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