Drugs

Y-mAbs Submitting Omburtamab Data Sought by FDA

Y-mAbs Therapeutics says it is collecting data from identified historical control groups sought by FDA for the company’s omburtamab, an investigational monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system administration. A company statement says the firm had a Type B meeting with the agency at which FDA requested the additional data concerning the granularity of data from the control groups.

Y-mAbs says it anticipates submitting the requested data before the end of April and has another Type B meeting set for 6/1 to discuss the statistical analysis plan based on the review of the additional data. It says it continues to project submission of a BLA for omburtamab late in the second quarter or the third quarter of this year.

Company officials say they believe the drug is on track to potentially become the first FDA-approved targeted therapy for pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

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