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Following an FDA import alert placed on a Chinese API manufacturer early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
A federal appeals court upheld that a Novartis patent for its multibillion-dollar MS drug Gilenya is invalid, opening the door for generics as early as 2019. Read More
Congress Friday unveiled its first draft of FDA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry. Read More
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More
Shire ViroPharma has asked a Delaware federal court to dismiss an FTC complaint accusing the drug company of abusing the citizen petition process. Read More