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The FTC is suing Endo Pharmaceuticals and several other drugmakers over what it calls the illegal use of pay-for-delay settlements to block the market entry of generic forms of Opana ER and Lidoderm. Read More
Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors of biosimilars incorporate into product labeling information from the reference product labeling. 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 issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency. 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