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With such a strong unmet need in severe asthma patients and convincing evidence of improvement in this population, Teva Pharmaceuticals’ candidate reslizumab warrants approval, FDA advisors said Wednesday. Read More
Participants in a Senate hearing Wednesday on drug price manipulation said the best way to stem the practice is to speed competitors to market and consider using compounders. Read More
Indian regulators have approved a generic version of Gilead’s hepatitis C drug Harvoni (ledipasvir-sofosbuvir) in a country with the highest infection rate on the planet. Read More
The FDA has granted orphan drug and rare pediatric disease designations to ARMGO Pharma’s ARM210 for the treatment of Duchenne Muscular Dystrophy. Read More
Physician groups frustrated with federal plans to pair different biosimilar drugs together for billing and reimbursement purposes are turning to Congress for help. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Wednesday. Read More