IND builds on previously-published, preliminary evidence of efficacy Filing is supported by robust manufacturing, pre-clinical and clinical data already reviewed by FDA for NRX-101 associated with ...
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 ...
First-in-class metal-modulating epigenetic therapy targeting iron-dependent pathways with preclinical efficacy and a favorable GLP safety profile. MIAMI, FL / ACCESS Newswire / March 31, 2026 / ...
LONDON, UK / ACCESS Newswire / April 14, 2026 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) is pleased to announce that it has submitted its Annual Report to the U.S. Food and Drug Administration (FDA) ...
CARLSBAD, Calif., Jan. 10, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target ...
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 ...
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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