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An FDA advisory committee voted on Tuesday to support withdrawal of FDA approval for AMAG Pharmaceuticals’ preterm birth injection Makena (hydroxyprogesterone caproate). Read More
“The incredible speed of this approval underscores our shared sense of urgency with the FDA and the CF community,” a Vertex spokesperson said. Read More
Novartis hit three generic drugmakers with a lawsuit in a Delaware federal court for patent infringement over its heart-failure drug Entresto (sacubitril/valsartan). Read More
Allergan announced that its subsidiary Forest Laboratories will pay $750 million to direct purchasers to settle allegations of anticompetitive behavior over the Alzheimer’s drug Namenda (memantine). Read More
Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance released on Monday. Read More
The facilities will be selected based on priorities identified for staff training, the facility’s compliance status, and on consultation with the FDA district office. Read More
The institute endorsed the medicine for patients with a high risk of atherothrombotic events if they are not at an increased risk for bleeding. Read More