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Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary. Read More
California Gov. Jerry Brown (D) Sunday vetoed a bill that would have allowed drugmakers to make experimental therapies available to terminally ill patients if recommended by two doctors, saying the FDA’s compassionate use program should be given a chance to work. Read More
The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
Novartis has launched a program to provide 15 drugs in Kenya, Ethiopia and Vietnam, with plans to eventually expand to 30 low- and middle-income countries. Read More
The FDA is heeding industry requests to simplify the ANDA approval process by allowing generics makers to submit proposed labeling instead of final printed labeling. Read More
Sen. David Vitter is asking the FDA to process its current backlog of more than 3,000 generic drug applications, especially in light of recent prescription drug price increases. Read More
Sandoz says the FDA has accepted its second biosimilar application, this one for a copy of Amgen’s autoimmune disease drug Enbrel, whose global sales of nearly $9 billion made it the world’s fifth-biggest selling medicine in 2014. Read More