FDA Policy/General

FDA Approves Merck’s Idvynso for Treating HIV

FDA has approved Merck’s Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed. The therapy combines doravirine and islatravir and is indicated as a replacement regimen for patients with HIV-1 RNA levels below 50 copies per milliliter who are stable on treatment, have no history of virologic failure, and show no resistance to doravirine.

The approval introduces the first complete, two-drug regimen that is both non–integrase inhibitor-based and free of tenofovir, expanding options in a treatment landscape largely dominated by three-drug combinations such as Gilead’s Biktarvy, according to Merck.

The approval is supported by data from two Phase 3 trials enrolling more than 700 virologically suppressed adults who were switched from existing regimens. Across studies, between 92% and 96% of patients receiving Idvynso maintained viral suppression at 48 weeks, consistent with comparator arms.

Safety findings were broadly comparable to standard regimens, with low discontinuation rates due to adverse events, according to the company. The most commonly reported side effects included diarrhea, dizziness, fatigue and headache. However, the label carries warnings for severe skin reactions, including Stevens-Johnson syndrome, and potential drug interactions that could reduce effectiveness or increase toxicity.

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