FDA Policy/General

Lagevrio Misses Endpoint in Covid-19 Study

Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not demonstrate a statistically significant reduction in the risk of Covid-19 in those who were exposed to the virus by another in their household. In the company’s Phase 3 MOVe-AHEAD trial, the Lagevrio-treated group was 23.6% less likely than those who received placebo to develop Covid-19 through day 14, which failed to meet the primary endpoint.

Lagevrio is a nucleoside analog that inhibits SARS-CoV-2 replication by viral mutagenesis, and marketed under an emergency use authorization for treating adults with a current diagnosis of mild-to-moderate Covid-2019 who are at high risk for progression to severe disease, according to Merck. It intends to submit full results from the study at a future scientific meeting, or for publication in a medical journal.

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