Latest News and Press Releases

Lexeo Therapeutics Announces FDA Breakthrough Therapy Designation for LX2006 in Friedreich Ataxia

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...

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...

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...

Global expansion into the Americas and Middle East fuels Rebirth Globe’s $15M growth projection for 2025

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...

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,...

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...

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. ...

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...