Drugs

Veklury Approved for Covid Plus Renal Impairment

FDA has approved a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those on dialysis. The approval now extends the drug’s use across all stages of renal disease, the company says.

Approval was based on data from a Phase 3 study (REDPINE) evaluating the efficacy and safety of Veklury in 243 hospitalized adult participants with confirmed Covid-19 and renal impairment who were randomized in a 2:1 manner to receive Veklury (n=163) or placebo (n=80). “No new safety signals were observed in the study and no additional adverse reactions to Veklury were identified in 163 hospitalized patients with confirmed Covid-19 and acute kidney injury (AKI) (n=60),” Gilead says.

According to the company Veklury works by inhibiting viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. “Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including BQ.1.1 and XBB,” it adds.

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