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Monday, Aug 25 2025

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FDA Shift In Drug Approvals Halts Trial Of Second Skin Cancer Drug

Krystal Biotech has suspended a study of a skin cancer therapy called KB707, citing a shift in the approach toward drug approvals by the regulatory agency.

The FDA鈥檚 rebuff of Replimune鈥檚 melanoma candidate has sent waves through the industry, prompting Krystal Biotech to shutter a clinical trial. Krystal Biotech has discontinued a phase 1/2 trial assessing intratumoral injections of KB707, a modified herpes simplex virus type 1-based gene therapy, for patients with advanced skin cancer. (Masson, 8/21)

President Trump鈥檚 repeated threats to impose punishing tariffs on imported medicines have sparked interest in where Americans鈥 drugs are produced. The picture is complex. Most of the time, drugs are not made in a single country from start to finish. More often, a factory imports raw materials that it uses to make a drug鈥檚 active ingredients, which then get shipped to a plant in another country that formulates the drug into a tablet or liquid. (Robbins and Corum, 8/23)

Amid demand for retraction, a leading medical journal is reviewing a study published in 2001 that touted the benefits of a depression pill for adolescents, but was subsequently discredited and became the focal point of a searing controversy over inappropriate marketing of the medicine. (Silverman, 8/25)

Patients using Ozempic and other GLP-1 drugs are reporting a complication not listed among the drug鈥檚 most common side effects. We鈥檙e not talking about 鈥淥zempic babies,鈥 but that鈥檚 also a thing. Dentists warn they鈥檙e seeing cases of something nicknamed 鈥淥zempic teeth.鈥 Medications like Ozempic and Wegovy can lead to dry mouth because the active ingredient, semaglutide, affects the salivary glands, explains Adam Taylor, an anatomy professor at Lancaster University, in an article for The Conversation. The medications can also cause people to drink less water because they feel less thirsty. (Martichoux, 8/23)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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