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The FDA has delivered PTC Therapeutics a stinging rebuke, sending the company a refuse to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. Read More
The response letter is for Merck’s sNDAs for cholesterol drugs Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease. Read More
Drug giant AstraZeneca has scored a big win in Europe, reeling in marketing authorization for Zurampic for patients with gout and a new dose of the heart medication Brilique. Read More
The UK’s National Institute for Health and Care Excellence delivered a stinging rebuke to Alexion Pharmaceuticals, saying it would not reimburse Kanuma for the treatment of lysosomal acid lipase deficiency until more evidence could support it. Read More