Boehringer Ingelheim's blockbuster anticoagulant Pradaxa resulted in more reports to the FDA of fatalities of than any other drug last year.
The FDA has cited Siemens Healthcare's diagnostics arm for marketing a diagnostic test system used to assess everything from allergies to anemia and hepatitis without formal approval.
A proposed House subcommittee budget would stick it to the FDA next year, proposing not only lower total dollars in FDA discretionary spending than suggested by the White House and Senate, but $16.3 million less than the current year.
Drugmakers are squaring off against the U.K.'s price-setting proposals.
Stryker ($SYK) expects it will pay $33 million to settle a federal investigation into the sales and marketing of its OtisKnee implant.
In another self-inflicted wound for Merck, the FDA has handed back its new drug application for ridaforolimus, saying the pharma giant will need to run additional clinical trials to test its effectiveness on sarcomas before it can issue an approval.
Amylin is looking to expand Bydureon, its Type 2 diabetes drug, with a new drug delivery method: pre-filled injection pens instead of syringes.
Zogenix has filed an investigational new drug application with the FDA for Relday, a schizophrenia treatment that uses the company's DosePro drug delivery tech.
WuXi PharmaTech calls the 2011 incident the only known case of its kind in its 11-year history.
As the U.S. House of Representatives gears up to vote on a bill that would repeal the 2.3% device industry tax this week, the Congressional Budget Office says the measure will place a hefty price tag on the federal budget.