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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
Antares acquired exclusive rights to Tlando from Salt Lake City, Utah-based Lipocine in October 2021 as part of a $21 million licensing deal. Read More
The FDA has accused a Polish company that manufactures and sells over-the-counter (OTC) products online of making a homeopathic drug cream that contains 100 million times the active concentration that the drug is purported to possess on its label. Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More