FDA Publishes Guidance on Therapeutic Protein Biosimilars
May 22nd 2019The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.
NIH Awards Grants to Advance STI Vaccine Development
May 13th 2019The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).
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