Biologics

Axogen Nerve Graft Review Extended by 3 Months

FDA has extended by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submitted by the company in response to an agency request was deemed a major amendment. The information submitted included substantial new manufacturing and facility data not previously reviewed by the agency, according to the company. As a result, FDA has set a revised user fee review action target date of 12/5. “The FDA also informed the company that it now anticipates providing feedback on product labeling in November 2025, consistent with PDUFA review procedures,” it adds.

The Avance Nerve Graft is a human nerve graft from a donor (allograft) that is processed to remove cells while retaining its natural, biologically active structure, according to the company. It is intended to act as a biologically active conduit to bridge the gap between severed peripheral nerves, providing a scaffold for the patient's own nerve cells to regenerate across the injury site.

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