Drugs

EUA for Merck’s Molnupiravir Covid Treatment

FDA has issued an emergency use authorization (EUA) for Merck’s molnupiravir for treating mild-to-moderate coronavirus disease in adults with positive results of direct SARS CoV-2 viral testing who are at high risk for progressing to severe Covid-19, including hospitalization or death, and for whom alternative Covid-19 treatment options authorized by FDA are not accessible or are clinically inappropriate. An agency statement says the prescription drug should be started as soon as possible after a Covid-19 diagnosis and within five days of symptom onset.

The statement says molnupiravir works by introducing errors into the SARS-CoV-2 virus genetic code that prevent the virus from further replicating.

The primary data supporting the EUA are from the MOVe-OUT trial that studied the drug for treating non-hospitalized patients with mild to moderate Covid-19 at high risk for progression to severe Covid-19 and/or hospitalization. Of 709 people who received the treatment, 6.8% were hospitalized or died within the 29-day follow-up period, compared with 9.7% of the 699 people who received a placebo. Side effects observed during the trial included diarrhea, nausea, and dizziness.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome