Solid Biosciences Inc. SLDB announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its novel AAV-based gene therapy candidate, SGT-212, for the ...

Plans for filing an IND was agreed with the FDA in a recent meeting –– Positive preclinical results of the small-diameter ATEV were recently ...

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.

Humacyte (HUMA) announced that it plans to file an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, ...

Solid Biosciences (SLDB) announced that the FDA has cleared its investigational new drug, or IND, application for SGT-212 for the treatment of Friedreich’s ataxia, a degenerative disease caused ...

IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC designed to precisely target Nectin-4, a cell adhesion ...

The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...

Currently, the DMD treatment landscape includes Sarepta’s Elevidys (delandistrogene moxeparvovec), the first FDA-approved ...

INCHEON, South Korea, Jan. 15, 2025 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced its innovative drug development strategy in the rigorous ...

The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...

Revidia Therapeutics Inc., a cardiac regenerative medicine company developing first-in-class small molecule drug therapies for heart injury, has announced that it has expanded its leadership team in ...

The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...