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Lexeo Therapeutics Announces FDA Breakthrough Therapy Designation for LX2006 in Friedreich Ataxia
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DURHAM, N.C., July 01, 2025 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life...
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FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark application filed with notified body to enable commercialization of the ARC-EX System...
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DALLAS, June 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation...
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Global expansion into the Americas and Middle East fuels Rebirth Globe’s $15M growth projection for 2025
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Ce jalon réglementaire marque l’entrée de TISSIUM sur le marché américain et établit les fondations de sa plateforme de polymères dédiés à la reconstruction atraumatique des tissus. Paris...
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This regulatory milestone marks TISSIUM’s entry into the U.S. market and establishes the foundation of the TISSIUM polymer platform for atraumatic tissue repair Paris, France, Cambridge, USA,...
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BPM31510 provides encouraging evidence of the potential for transformative benefit for a disease with high unmet need, supporting further development.The Company plans to seek guidance in Q3 2025 from...
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Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases. ...
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SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the...