The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
This recommendation is based on new data from two randomized controlled trials involving 3078 patients
Terran to advance the development of two of Sanofi's Phase 3 CNS therapeutics
Key findings underscore the need for better control of glycemia, blood pressure and lipid parameters to prevent diabetes-related complications
With the commercialization of Qvella technology for Positive Blood Culture (PBC) processing, healthcare facilities can now get results up to 24 hours faster than current methods
Company has invested $150 million to build a 150,000 square-foot commercial manufacturing facility in Research Triangle Park (RTP), North Carolina
Bringing together Bristol Myers Squibb and Celgene on one clinical trial management system, company goes live with Vault CTMS in record speed
Pre-exposure prevention trial reduced risk of symptomatic Covid-19, with no severe disease or Covid-19-related deaths in the Evusheld group
Immune response confirmed in stand-alone influenza vaccine and combination vaccine with a potential path forward for both
Support for biologics manufacturability and Industry 4.0 initiatives
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