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The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
A month after the FDA announced a nationwide sweep that resulted in criminal and civil cases against 89 makers of dietary supplements, a former owner and operator of a Montana dietary supplement maker has been sentenced to prison for selling supplements in violation of two court orders. Read More
An FDA advisory committee Tuesday erected another roadblock for getting Fabre-Kramer’s depression candidate gepirone on the market, recommending against approving a potential therapy whose fate has been in limbo for two decades. Read More
Gilead Sciences put profit over affordability when pricing its line of hepatitis C treatments, says a Senate Finance Committee report issued Tuesday. Read More
The FDA has rejected Repros Therapeutics’ NDA for its secondary hypogonadism treatment enclomiphene, asking the drugmaker to conduct an additional Phase 3 study or studies, as the original trials are no longer adequate to demonstrate clinical benefit. Read More
The nation’s largest pharmacy benefits manager is throwing its support behind a cheaper alternative to Turing Pharmaceuticals’ expensive toxoplasmosis/HIV treatment, threatening its monopoly on the market. Read More