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The FDA cited Sunstar for serious violations at a manufacturing facility in China, issuing the firm a warning letter for failing to test incoming drug components and finished products, among other violations. Read More
In comments to the FDA, multiple drugmakers urged the agency to expand the scope of its planned pilot for reviewing novel excipients outside of drug applications. Read More
The Patent Trial and Appeal Board sided with Biogen in Mylan’s patent challenge over Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate). Read More
In his State of the Union address last night, President Trump called on Congress to pass legislation to curb the nation’s high drug prices, saying he would sign a bipartisan bill into law if it reached the Oval Office. He did not mention insulin pricing as expected. Read More
The FDA hit a Tijuana drug manufacturer with a warning letter for shoddy investigations into microbiological contamination and other serious violations observed during an agency inspection. Read More
A U.S. court has ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued in December 2018 for the company’s long-term study of tradipitant. Read More
In the wake of declaring the coronavirus a global emergency, the World Health Organization (WHO) has issued a new procedure for drugmakers that wish to submit unapproved drug products for public health crises. Read More