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The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that drug bound to about half of the oral medications tested. Read More
The FDA has approved Merrimack Pharmaceuticals’ Onivyde, the first and only treatment for patients with advanced pancreatic cancer whose disease progressed after getting chemotherapy with gemcitabine. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Led by complaints about plaque psoriasis drugs, the FDA Adverse Event Reporting System recorded 205,389 primary suspect adverse event reports for 2,038 drugs in the second quarter of 2015, according to a new report by Advera Health Analytics. Read More
The FDA Wednesday approved Relypsa’s hyperkalemia therapy Veltassa — the company’s first product and the first advance in treating the life-threatening condition in more than five decades. Read More