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The FDA and Amarin get another month to settle their differences over the drugmaker’s efforts to promote its cholesterol drug Vascepa off-label. Read More
In a case with broad implications for medical patent protection, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Tuesday. Read More
The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections. Read More
The FDA has delivered PTC Therapeutics a stinging rebuke, sending the company a refuse to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. Read More