Drugs

XO Biologix Marketing Unapproved, Adulterated Drug

A 1/3-1/5/2024 FDA inspection at XO Biologix in Austin, TX, determined that the company markets and distributes a product derived from amniotic fluid under a redacted contract. A just-released 12/12/2024 Warning Letter says the company’s MaviX product is an unapproved new drug and an unlicensed biological product.

MaviX also is adulterated, the letter says, due to significant violations of current good manufacturing practice (CGMP) requirements that were outlined in another Warning Letter.

Finally, FDA says the product is misbranded because the labeling‘s instructions for use are false and misleading.

XO Biologix was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with documentation showing that the matters have been addressed and a schedule for completing the corrections.

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