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FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers

The need to diversify and strengthen the U.S. infant formula supply is more important than ever. The recent shutdown of a major infant formula...

Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, participated in the U.S. Food and Drug Administration...

MCRA and Clients Achieve Significant Milestone – Over 60 Breakthrough Device Designations

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations,...

Sonivie Receives Ide Approval From FDA for Its Pilot Study to Treat Hypertension

SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS™) to treat a variety of hypertensive disorders, announced that on May...

FDA Advisory Committee Unanimously Endorses eli-cel Gene Therapy for Cerebral Adrenoleukodystrophy

bluebird bio, Inc. announced the outcome of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) discussion of...
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