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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
FDA reviewers are questioning the safety and dosing of AztraZeneca’s investigational gout treatment lesinurad and whether a risk evaluation and mitigation strategy would suffice to address those concerns. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More