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Sen. Charles Grassley (R-Iowa) has sent a letter to the Centers for Medicare and Medicaid Services, asking for investigation of the classification of Dilaudid and Prilosec. Read More
Sanofi and Regeneron intend to appeal a federal court injunction banning the sale of their cholesterol drug Praluent after a judge found the companies infringed an Amgen patent covering its Repatha. Read More
Following tradition, FDA Commissioner Robert Califf will leave the agency on Inauguration Day, when Stephen Ostroff — deputy commissioner for foods and veterinary medicine — will temporarily assume the role. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More