The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...
HOUSTON, Dec. 31, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeuti ...
NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease. The Company expects to initiate a Phase 1 ...
World’s First IND Approval in Oncology Based Solely on Human Vascularized Organoid Efficacy Data Confirms Shift Toward Human-Relevant Preclinical Testing SAN DIEGO, Calif. – October 27, 2025 – ...
Askbio Inc., a subsidiary of Bayer AG, has received IND clearance from the FDA for AB-1009, an AAV gene therapy being developed for the treatment of late-onset Pompe disease.
GenEditBio Limited ("GenEditBio"), a clinical-stage biotechnology startup focusing on genome-editing therapeutic solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address ...
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