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 ...

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 ...

has cleared the Company’s Investigational New Drug (IND) application for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor in ...

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

cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive ...

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 ...

Despite significant advancements in immunotherapy and molecular targeted therapies in recent years, the demand for innovative drugs and new treatment options continues to grow among clinicians and ...

INCHEON, South Korea, Jan. 15, 2025 /PRNewswire/ — Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, ...