FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
The Phase 1/2 trial is a first-in-human, open-label, multi-national study designed to evaluate the safety, tolerability, and efficacy of TSRA-196 in adults with AATD. Trial participants will receive a ...
The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to ...
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has ...
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, ...
A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies ...
Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration ...
Abpro announced, together with its co-development partner Celltrion, that the U.S. Food and Drug Administration, FDA, has cleared the ...
InvestorsHub on MSN
Compass Pathways gains after FDA clears IND for PTSD trial of COMP360
Shares of Compass Pathways Plc (NASDAQ:CMPS) rose about 3% in premarket trading on Wednesday after the company said the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND ...
The US Food and Drug Administration (FDA) has cleared GenEditBio Limited’s Investigational New Drug (IND) application to ...
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