Biologics

Revance BLA Final Review Action Deferred Due to Covid

FDA has deferred its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodulator for treating moderate to severe glabellar (frown) lines. The agency said a required inspection could not be conducted at the company’s northern California manufacturing facility due travel restrictions associated with the Covid-19 pandemic. Revance says it confirmed with FDA that their communication was not a complete response letter. “Though the company’s BLA is still under review, the FDA did not indicate there are any other review issues at this time, beyond the on-site inspection,” it says. “The FDA stated they are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.” Revance describes daxibotulinumtoxinA as a proprietary stabilizing peptide excipient combined with a highly purified botulinum toxin that does not contain human or animal-based components.

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