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The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Roseville, Minn.-based Rebiotix has been granted FDA breakthrough therapy status for its lead product RBX2660 to treat recurrent Clostridium difficile infection. Read More
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The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs.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