Drugs

Create ‘Enhanced Drugs’ Pathway: Petition

Age Reversal Unity, an advocacy organization founded in 2024 to lobby FDA to reclassify aging as a disease rather than a natural process, is petitioning the agency to create a regulatory pathway for so-called enhanced drugs, which it defines as “substances intended to make humans enhanced and superhuman, including but not limited to physical, cognitive, or biological enhancements that extend beyond the normal healthy human range.” The 9/25 petition says that while regulatory frameworks only approve drugs for the prevention, treatment, or mitigation of disease, modern science and technology are rapidly producing compounds and biologics with enhancement effects that are not disease-related, but instead intended to elevate human ability.

The group says FDA has authority to regulate enhanced drugs because they are intended to affect the structure or function of the body.

“There is currently no regulatory pathway for a company or researcher to obtain FDA approval of an enhanced drug for the purpose of making humans ‘superhuman’ or beyond normal capacity,” the petition concludes. “This regulatory gap leaves both innovators and consumers without a safe, lawful avenue. For these reasons, FDA should create and recognize a new category of enhanced drugs that specifically covers enhancement and superhuman applications.”

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