
- November 2025
- Volume 91
- Issue 11
November 2025 Trending Products
Key Takeaways
- Guselkumab is the first IL-23 inhibitor approved for pediatric plaque psoriasis and psoriatic arthritis, based on the PROTOSTAR trial results.
- Paltusotine is the first oral treatment for acromegaly, approved following successful phase 3 trials, offering a new option for patients with inadequate surgical outcomes.
Guselkumab and paltusotine received FDA approval, Kenvue announced the new Tylenol Precise Pain-Relieving Patch, and a new generic version of mifepristone received the green light from the FDA.
Rx Products
Guselkumab (Tremfya)
From: Johnson & Johnson
The FDA approved guselkumab (Tremfya; Johnson & Johnson) for the treatment of children aged 6 years and older who weigh at least 40 kg and have either moderate to severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA).¹ This action makes guselkumab the first IL-23 inhibitor available for pediatric patients, extending its prior approvals in adults with PsO in 2017 and PsA in 2020. Guselkumab is a fully human, dual-acting monoclonal antibody that obstructs IL-23 and attaches to the CD64 receptor on IL-23–producing cells. The pediatric approval was primarily based on results from the phase 3 PROTOSTAR trial (NCT03451851), which evaluated guselkumab in children with moderate to severe plaque PsO. At week 16, guselkumab demonstrated significantly higher rates of response compared with placebo.
For more information: tremfya.com
Paltusotine (Palsonify)
From: Crinetics Pharmaceuticals
The FDA has approved paltusotine (Palsonify; Crinetics Pharmaceuticals, Inc) for first-line treatment of adults with acromegaly who had an inadequate response to surgery or for whom surgery is not an option. This approval marks paltusotine—a somatostatin receptor agonist—as the first once-daily, oral treatment granted for this patient population, supported by data from 2 phase 3 pivotal trials, PATHFNDR-1 (NCT04837040) and PATHFNDR-2 (NCT05192382). Acromegaly is a rare condition in adults that causes some bones, organs, and other tissues to grow bigger, driven by too much growth hormone in the pituitary gland, which is in the brain. Symptoms of the condition alter the way some body parts appear, including thick ears and lips, a broad nose, enlarged hands and feet, a jutting brow or jaw, gaps between teeth, an enlarged tongue, and an expanded rib cage that may cause the chest to have a round shape.
For more information: palsonify.com
OTC Product
Tylenol Precise Pain-Relieving Patch
From: Kenvue
Tylenol has introduced Tylenol Precise Pain-Relieving Patch, a new topical product designed to deliver flexible, discreet, and long-lasting pain relief. Formulated with 4% lidocaine—the maximum strength available over the counter—the patch targets muscle and joint discomfort without the need for a prescription. The translucent, breathable design allows the patch to move with the body, maintaining comfort and adhesion through sweat and motion. Gentle enough for all skin types, the single-use patches can be applied to the back, knees, or shoulders and worn for up to 12 hours. Notably, the patches do not contain acetaminophen, underscoring their targeted role as a topical solution.
For more information: tylenol.com
Generic Product
Mifepristone
Compare to: Mifeprex
From: Evita Solutions
The FDA approved a new generic of mifepristone (Danco Laboratories) available in 200-mg oral tablets, quietly widening the options for aborting pregnancy. Mifepristone carries out about two-thirds of medical terminations of pregnancy. Mifepristone, which was initially approved by the FDA in 2000 and had its first generic version approved in 2019, is indicated with misoprostol for the medical termination of a pregnancy that is less than 70 days of gestation. The regimen requires patients 17 years or older to take a single 200-mg oral dose of mifepristone tablet, then 4 oral doses of misoprostol (200 mcg) administered 24 to 48 hours after the former. It stops the supply of hormones that maintain the interior of the uterus; without these hormones, the uterus cannot continue to support the pregnancy and expels the contents within the organ. The FDA emphasized that the generic version will be subject to the existing Mifepristone Risk Evaluation and Mitigation Strategy program.
For more information: evitasolutionsllc.com
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