BlueRock Therapeutics has obtained FDA approval for their IND application for OpCT-001, a cell therapy derived from iPSCs, targeting primary photoreceptor diseases.
GC Biopharma revealed that its joint effort with Hanmi Pharmaceutical on the Fabry treatment 'LA-GLA' (GC1134A/HM15421) has been granted IND approval by the U.S. FDA to initiate a Phase 1/2 clinical study.
REGENXBIO Inc. revealed encouraging findings from the Phase I/II/III CAMPSIITE® study of RGX-121, aimed at treating Mucopolysaccharidosis Type II (MPS II).
The EC has authorized the use of Merck's KEYTRUDA® (pembrolizumab) in combination with Padcev® (enfortumab vedotin-ejfv) as an initial therapy for adults with inoperable or metastatic urothelial cancer.
This FDA approval of the ARCT-032 IND application allows the Company to commence a Phase 2 multiple ascending dose study to assess the safety, tolerability, and efficacy.
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the National Medical Products Administration (NMPA) has approved their investigational new drug (IND) application for the clinical trial of HLX17
IgGenix revealed promising data about its primary candidate, IGNX001. This candidate is an IgG4 monoclonal antibody therapy designed to treat peanut allergy.