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Two FDA advisory committees voted late Wednesday to recommend approval of Amgen’s talimogene laherparepvec immunotherapy for patients with metastatic melanoma, overriding FDA reviewers’ concerns that results from a pivotal clinical trial were skewed. Read More
The FDA has agreed to fast track its review of a new indication for AstraZeneca’s blood-thinning drug Brilinta, meaning the therapy could be available for patients with a history of heart attacks by the third quarter of 2015. Read More
The FDA says it plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More
Takeda said Wednesday it will pay up to $2.4 billion to settle the majority of U.S. lawsuits involving its diabetes drug Actos, which has been linked to cancer. Read More
Particulates continue to be a major cause of recalled injectables, with Mylan on April 23 recalling eight lots of four drugs after foreign matter was found during quality control tests. Read More
Generic and brand drugmakers continue to push for an expedited agency review process with clearly defined timelines for updating drug labels based on safety information, according to comments on the FDA’s proposed drug labeling rule. Read More
Nearly three years after generics giant Mylan accused Warner Chilcott and Mayne Pharmaceuticals of “product hopping” with their acne medication Doryx, a federal judge has dismissed the case, ruling in favor of the brandmakers. Read More
The Federal Trade Commission can pursue billions of dollars in repayments from Cephalon over alleged pay-for-delay tactics to stall the marketing of a generic version of Provigil, the brandmaker’s narcolepsy drug. Read More
Mylan has settled patent litigation related to Pfizer’s Viagra, paving the way for generic copies of the erectile dysfunction blockbuster in the U.S. in 19 months. Read More