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The FDA has approved a supplemental application for abortion drug Mifeprex, updating the label to lower the dosage and extend the usage period to 70 days gestation from 49. Read More
Dublin, Ireland-based Jazz Pharmaceuticals has scooped up FDA approval for its hepatic veno-occlusive disease treatment Defitelio, the first approved therapy to treat the rare and life-threatening liver condition. Read More
Aveo Pharmaceuticals will pay $4 million to settle SEC claims that it and three former executives misled investors for nearly a year about regulatory roadblocks facing one of its candidates. Read More
The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483. Read More
The FDA has sped up its review time of new drugs markedly in the last five years, decreasing its average time for a decision from 21 months to 10 months in 2015, according to a new report. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More
Eagle Pharmaceuticals is objecting to the FDA’s decision to grant orphan drug Bendeka only three years of exclusivity instead of the full seven years and says it may take action. Read More