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A Janssen production plant that turned heads for its continuous production line was handed a 483 two months prior to switching the line from batch production. Read More
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement on Wednesday, but left the door open to further discussion. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
A Merck unit will lose four of its five patents on its skin infection therapy Cubicin after the U.S. Supreme Court denied the drugmaker’s appeal Tuesday. Read More
Chronic liver disease candidate Ocaliva and the self-administered multiple sclerosis treatment Zinbryta both snagged FDA approval late Friday. Read More
Two compounders are facing FDA warning letters for sterility concerns, with one company being pummeled for numerous other quality deficiencies. Read More
Two foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More