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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
Sanofi and Regeneron’s biweekly injectable Praluent effectively lowers bad LDL cholesterol and has few side effects, the FDA says in briefing materials released ahead of a Tuesday advisory committee meeting. Read More
The UK’s National Institute for Health and Care Excellence issued draft guidance Friday on two prostate cancer drugs, recommending Bayer’s Xofigo while declining to endorse Ferring Pharmaceuticals’ Firmagon. Read More