The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...
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Biogen Advances New SKYCLARYS Formulation in Early Trial, Supporting Long-Term Rare Disease Strategy
Biogen Inc. announced an update on their ongoing clinical study. Claim 70% Off TipRanks Premium. Unlock hedge fund-level data and powerful investing tools for smarter, sharper dec ...
NEW HAVEN, Conn., Nov. 6, 2017 /PRNewswire/ -- (NYSE: BHVN) - Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven" or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc.
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) ...
VANCOUVER, BC / ACCESS Newswire / April 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery ...
Raman Spectroscopy and MDRS Enable Determination of the Size and Shape of Specific Components Within a Multicomponent Blend Reviewing the recent approval of an abbreviated new drug application (ANDA) ...
Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...
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