Johnson & Johnson, the world’s second-biggest health-care products maker, is battling lawsuits over a vaginal implant based on a similar device pulled from the market more than a decade ago for safety reasons.
Medical device makers Medtronic Inc. , Johnson & Johnson and Stryker Corp . face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.
A program allowing U.S. regulators to approve moderate-risk medical devices in an average of 10 months instead of years shouldn’t be scrapped, the Food and Drug Administration said in response to an advisory panel report.
Arena Pharmaceuticals Inc. fell in early trading after the company failed to win U.S. approval for diet pill lorcaserin as an advisory panel said the weight loss achieved with the medicine didn’t justify the risk of cancer.