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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
This week is shaping up to be a busy one for FDA reviewers, with decisions due on four NDAs for drugs to treat hyperkalemia, chronic pain and cancer. Read More
The FDA dealt Shire’s promising dry eye treatment lifitegrast a setback, requesting an additional clinical study and more product quality information just days before the drug’s anticipated approval date. Read More
A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous. Read More