FDA OKs First ‘Targeted Treatment’ for Rare DMD Mutation

The US Food and Drug Administration (FDA) has approved the antisense oligonucleotide casimersen (Amondys 45, Sarepta Therapeutics) injection for the treatment of patients with Duchenne muscular dystrophy (DMD) plus a rare DMD mutation, the agency has announced.  This particular mutation of the DMD gene “is amenable to exon 45 skipping,” the FDA noted in a press release. It added that […]

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Task Force Tackles FDA Lamotrigine Cardiac Risk Warning

A joint task force of the American Epilepsy Society (AES) and International League Against Epilepsy (ILAE) has issued an advisory to address concerns arising from a Food and Drug Administration (FDA) warning of cardiac risk in patients taking the antiseizure drug lamotrigine. The task force is concerned that the FDA warning is based on data not yet widely available, and […]

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