Drugs

FDA Accepts BioMarin Voxzogo New Indication sBLA

FDA has accepted for review a BioMarin sBLA seeking an expanded indication for its Voxzogo (vosoritide) for injection to treat children under age 5 with achondroplasia. The agency set a PDUFA target action date of 10/21.

The company says the sBLA is supported by results from a Phase 2 trial that demonstrated similar safety and efficacy profiles in children under age 5 as compared to those age 5 and older.

Voxzogo is described as a C-type natriuretic peptide analog that represents a new class of therapy by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor gene 3 to promote endochondral bone growth.

The drug received FDA accelerated approval on 10/19/21 to increase linear growth in pediatric patients with achondroplasia who are age 5 and older with open epiphyses.

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