Drugs

FDA Seeks Expanded Use of Testosterone Therapies

FDA is signaling a potential expansion of testosterone replacement therapy (TRT) use, encouraging drugmakers to explore whether existing products could be approved to treat low libido in men with idiopathic hypogonadism, according to a new agency notice. The move marks an early regulatory step that could broaden the scope of TRT beyond its current, more narrowly defined indications. Today, FDA-approved testosterone therapies are limited to men with hypogonadism linked to identifiable structural or genetic causes.

FDA commissioner Marty Makary says emerging evidence suggests a possible opportunity to address symptoms that can significantly affect quality of life. “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” Makary is quoted in the notice as saying, adding that the agency is prepared to work with sponsors while maintaining its standards for safety and effectiveness.

The agency’s position follows a preliminary review of published clinical studies, as well as input from a 12/2025 expert panel. According to FDA, these data indicate TRT may be both safe and effective for certain men experiencing low libido associated with idiopathic hypogonadism — a condition defined by low testosterone levels without a clearly identifiable cause.

Under the approach outlined by FDA, companies holding approved new drug applications for TRT products are invited to engage with the agency about pursuing a supplemental approval for the new indication. Sponsors would need to submit additional clinical data demonstrating that TRT provides a meaningful benefit in treating low libido in this patient population and that its risks are acceptable.

The agency set a 4/30 deadline for interested application holders to initiate contact. FDA emphasizes that any label expansion would require “substantial evidence” of effectiveness, consistent with its statutory approval standard, and a favorable benefit-risk profile for the intended population.

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