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MCRA Assists NeuroMetrix with obtaining FDA Breakthrough Device Designation and Marketing Authorization

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...

GenScript ProBio and DAAN Bio Therapeutics, Sign a Strategic Cooperation MOU for the Discovery and Development of Novel Drugs

GenScript ProBio (Brian Ho-sung Min, CEO), a global CDMO, and DAAN Bio Therapeutics (Byoung Chul Cho, Co-Founder & CEO), an innovative new drug developer...

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)...

Novan Announces Publication of Positive Results from Pivotal Phase 3 Study of Berdazimer Gel

Novan, Inc., announced today the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer...

FDA Grants Alpheus Medical Orphan Drug and Fast Track Designations for Novel Sonodynamic Therapy for Brain Cancer

Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, announced the U.S. Food and Drug...
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