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Discount store chain Dollar Tree was hit with an FDA warning letter for receiving adulterated over-the-counter drug products from foreign drugmakers in hot water with the agency. Read More
An FDA advisory committee voted unanimously on Thursday to recommend approval of Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events in adults. Read More
An HHS proposed rule currently under review at the Office of Management and Budget would have the U.S. pay less than other developed countries for some Medicare drugs by using a “most favored nation” approach, HHS Secretary Alex Azar said Wednesday. Read More
Indian drugmaker Cadila Healthcare was slapped with an FDA warning letter for serious violations at its injectable drug manufacturing facility in Ahmedabad, including cross-contamination from non-dedicated equipment. Read More
The House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill on Wednesday aimed at ending the abuse of citizen petitions to stall generic approvals. Read More
Teva Pharmaceuticals has been hit with a patent infringement suit in a Delaware district court by Switzerland-based Ibsa Pharmaceuticals and Altergon over its generic version of Ibsa’s hypothyroidism treatment Tirosint (levothyroxine). Read More
An FDA advisory committee voted on Wednesday to turn down Boehringer Ingelheim’s empagliflozin oral tablets in 2.5 mg doses for type 1 diabetes. Read More