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The U.S. Court of Appeals for the Federal Circuit upheld a 2017 ruling by the Patent Trials and Appeals Board rejecting Forward Pharma’s challenge to Biogen’s Tecfidera patent. Read More
The agency pointed out in its denial letter that the 180-day exclusivity period did not begin until Aug. 29, when the company actually notified the agency that it had begun commercial marketing. Read More
“Research suggests that using these formats to express probabilities when communicating health information can improve consumers’ comprehension and ability to recall the information” and improve their processing and evaluation, the agency said. Read More
The committee agreed that the company’s trial data showed the drug to be effective and that it adequately addressed the potential risk of cardiovascular adverse events. Read More
The FDA cited an API manufacturing facility in Torrance, California, for deficiencies in quality assurance, preventive maintenance, audits and batch records. Read More
The FDA issued draft guidance Wednesday that outlines what the agency considers an ideal and robust verification system to be that’s also in line with legislative requirements. Read More
President Trump signed a massive anti-opioid legislative package Wednesday and gave an update on the administration’s efforts to deal with the opioid addiction crisis. Read More