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In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who blamed inadequate labeling of its testosterone drug AndroGel for his heart attack. Read More
France’s Agency for the Safety of Health Products cited Chinese API manufacturer Chongqing Succeway Pharmaceutical for GMP non-compliance, including one critical finding — active tampering with company data. Read More
The FDA established a public docket so companies can nominate drug products or categories for the agency’s Difficult to Compound List — which blocks pharmacies from compounding certain products unless they are listed as a manufacturer. Read More
Sen. Claire McCaskill (D-Mo.) expanded her congressional investigation into opioid manufacturers and distributors, sending document requests to an additional four drugmakers. Read More
FDA Commissioner Scott Gottlieb updated lawmakers Thursday on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals. Read More
The PRIME designation was based on clinical data from a Phase I resection study in patients with recurrent brain cancer and results from preclinical models. Read More