Drugs

FDA Denies Petition Seeking Accelerated Aging Therapies

FDA has denied an 8/17/2025 petition filed by Age Reversal Unity seeking a regulatory framework for conducting expedited clinical trials of aging-related therapeutics within a nine-month timeframe. The agency’s denial letter says, “FDA does believe that issuing such a one-size-fits-all framework is scientifically appropriate or in the best interests of public health.” It notes there are many different types of diseases and conditions that are more prevalent in the older adult population, and the appropriate clinical trial endpoints for the diseases and conditions will vary depending on factors such as the disease or condition under study, investigational drug, patient population, clinical setting, phase of drug development, and disease severity.

Likewise, FDA says, the appropriate duration of a clinical trial is case-specific and considers the time necessary to evaluate the clinical endpoint of interest and the ability to collect data necessary to evaluate the investigational drug’s safety.

The letter says FDA has determined that no new regulatory framework or guidance is necessary for sponsors to use efficient clinical trial designs or expedited programs.

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