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A federal judge has ruled that a class-action antitrust lawsuit against several generics manufacturers, alleging price-fixing of propranolol capsules and tablets, can proceed in court. 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
In a Senate committee markup scheduled for May 10, lawmakers will consider the next generation of the FDA’s generic user fee program, using dollar amounts negotiated over the last two years with industry. Read More
The FDA’s proposed plan for spending the $500 million allocated by the 21st Century Cures Act through fiscal 2025 prioritizes patient-focused drug development, qualification of biomarkers, and the use of real-world evidence. Read More