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The approval was supported by positive data from two pivotal studies in which patients showed significant improvement in the disease over those who received a placebo. Read More
The FDA has released four related final guidances to help drugmakers submit electronic safety reports — including advice on how to conform to the latest International Council for Harmonization (ICH) standard. Read More
The FDA issued a Form 483 with nine observations to generics manufacturer Aurolife Pharma following a six-week inspection of the company’s manufacturing facility in Dayton, N.J., from Oct. 25 through Dec. 7, in which the company attributed some of its data deficiencies to a cyberattack. Read More
SK Bioscience said it also plans to submit emergency use applications to the World Health Organization and to regulatory agencies around the world. Read More
The European Commission has approved Merck’s blockbuster oncology drug Keytruda (pembrolizumab) for six new indications, including persistent, recurrent or metastatic cervical cancer. Read More
Government Accountability Office (GAO) officials testified on Friday before a House subcommittee where they highlighted the lack of procedures in four public health agencies — including the FDA — for reporting potential political interference. Read More
The FDA has announced tentative dates for its vaccine-related advisory committee to meet to discuss the much-anticipated full applications for Emergency Use Authorization (EUA) that it expects any day from COVID-19 vaccine manufacturers for children under age six. Read More