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U.S. FDA

U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373)...

SCG Cell Therapy Announces U.S FDA Clearance of Investigational New Drug Application

Singapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for...

CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal

CNS Pharmaceuticals, Inc., a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous...

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare...

U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by Innovent and IASO Bio

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major...
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