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The EMA’s Committee for Medicinal Products for Human Use recommended seven medicines for approval at its September meeting, including three new drugs, three generics and one orphan drug. Read More
Bipartisan leaders of the House Energy and Commerce Committee sent letters to 16 states asking for details of how they are using federal funds to combat the opioid crisis. Read More
Acting FDA Commissioner Ned Sharpless issued a statement on Friday on the agency’s efforts to increase the availability of naloxone — and to clear up confusion over how the injectable form of the opioid overdose drug can be dispensed. Read More
A House subcommittee on Thursday heard how some branded drugmakers game the system by reformulating their products solely to block competitors. Read More
House Speaker Nancy Pelosi on Thursday released her much-anticipated drug pricing bill that would allow the government to negotiate drug prices directly with drug manufacturers. Read More
Eli Lilly filed separate suits against the generic manufacturers in 2016 in the U.S. District Court for the Southern District of Indiana, arguing that their ANDAs infringed on its patent. Read More
Nine senators — including eight democrats and one independent — have urged the Federal Trade Commission to “closely scrutinize” AbbVie’s proposed $63 billion merger with Allergan and Bristol-Myers Squibb’s proposed $74 billion merger with Celgene. Read More
Novartis announced Wednesday that it is halting distribution of generic Zantac (ranitidine) globally amid ongoing investigations into ranitidine drugs containing a potential carcinogen. Read More
The FDA features the misuse of petitions to stall generic drug applications in a final guidance issued Wednesday — and spells out how the agency will deal with the petitions. Read More