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The FDA handed the medication breakthrough therapy, fast track, orphan drug, and rare pediatric disease designations, as well as priority review. Read More
The board found that Pfenex had a “reasonable likelihood” of proving that its cited prior art would have rendered two of the challenged claims unpatentable. Read More
The firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specification,” the agency said. Read More
The committee unanimously agreed that the company provided sufficient evidence that the drug reduced the risk of cardiovascular events in conjunction with statin therapy in adults with elevated triglyceride levels. Read More