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The Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 3 Tuesday to recommend approval of Sanofi and Regeneron’s cholesterol-lowering drug Praluent, but said more data is needed to support the drug’s effect on cardiovascular outcomes. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
Amgen’s injectable Repatha proved effective in lowering bad LDL cholesterol in a series of Phase 3 trials, but the FDA says some safety concerns remain. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More