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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
The FDA included detailed recommendations for booster shot studies in a final guidance on Emergency Use Authorizations (EUAs) for COVID-19 vaccines released yesterday. Read More
The Department of Justice (DOJ) is reportedly investigating a large prescription drug-trafficking network that allegedly has and is selling hundreds of millions of dollars of counterfeit HIV medications. Read More