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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
Drugmakers want the FDA to provide more details and examples of how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA hopes to cut down on patient-to-patient transmission of blood-borne infections by clearly labeling injectable therapies that are meant to be used multiple times by a single patient as products for “single-patient-use.” Read More