Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announces that it has received ...
U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period. Proposed phase I/II trial ...
Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) paves the way for ISM8969 clinical study in the United States. The Phase I clinical trial aims to evaluate ...
IRVINE, Calif., March 23, 2026 /PRNewswire/ -- EndoCyclic Therapeutics, a biopharmaceutical company developing precision peptide therapeutics and diagnostics for complex diseases, today announced that ...
GH Research is advancing GH001, an inhaled mebufotenin therapy for treatment-resistant depression, with a critical FDA IND update imminent. GH001 demonstrated robust Phase 2b efficacy—a 15.5-point ...
A new draft guidance from the US Food and Drug Administration (FDA) gives cell and gene therapy developers a detailed framework for the conduct of umbrella trials, offering the potential for enhanced ...
IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma ...
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