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).

Evommune has announced the initiation of a Phase 2 trial for EVO756, with the first patient now enrolled.

LENZ Therapeutics, a biopharmaceutical company dedicated to developing the first and only eye drop based on aceclidine (LNZ100) to improve near vision in presbyopia patients.

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.

Bispecific antibodies (commonly abbreviated as BsAbs) are an innovative class of biological drugs capable of simultaneously binding to two different antigens or epitopes.

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.

Sep 5th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

Antabio has reported the successful completion of its Phase 1 clinical trial for MEM-ANT3310 conducted with healthy participants.

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.

Finerenone significantly improved cardiovascular outcomes in adults with a prevalent form of heart failure, addressing a significant medical need.