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Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will attempt to grapple with the problem of SARS-CoV-2’s vexing ability to escape vaccine coverage. Read More
The International Council for Harmonization (ICH) has issued two draft guidelines to help drugmakers improve analytical testing used to assess product quality. Read More
German device manufacturer Fresenius Kabi is acquiring a majority stake in mAbxience, the biosimilars division of Madrid, Spain-based Insud Pharma, for $547 million. Read More
The FDA has placed a partial clinical hold on CytoDyn’s human immunodeficiency virus (HIV) program and a full clinical hold on its COVID-19 program in the U.S. Read More