FDA Revokes Emergency Use of Solo Bamlanivimab for COVID

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has granted Eli Lilly’s request to revoke emergency use authorization for the COVID-19 monoclonal antibody therapy bamlanivimab when used as a monotherapy, saying the evidence indicates that it is likely not effective against currently circulating variants. The agency said in […]

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FAQ: What to Know About the J&J Vaccine Pause

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. After receiving reports of a rare blood clot in people receiving the Johnson & Johnson COVID-19 vaccine, the FDA and the CDC have recommended a pause in the use of the vaccine, pending further investigation. Here is what you need to know: Why was the pause […]

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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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