Month: July 2023

The U.S. Food and Drug Administration (FDA) has approved two medications, Jardiance and Synjardy, as treatment options for children aged 10 and older with type 2 diabetes. This is significant, as children with type 2 diabetes have limited treatment options compared to adults. Type 2 diabetes is a chronic condition where the body does not […]

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The U.S. Food and Drug Administration (FDA) has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors known to appeal to youth, such as bubblegum and cotton candy. The FDA is committed to using all of its […]

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The U.S. Food and Drug Administration (FDA) has converted the drug Leqembi (lecanemab-irmb) from accelerated approval to traditional approval for the treatment of Alzheimer’s disease. This decision was made after a confirmatory trial showed that the drug provides clinical benefit. Leqembi is the first amyloid beta-directed antibody to receive traditional approval for Alzheimer’s disease. The […]

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Eisai, a Tokyo-based pharmaceutical company, has received full FDA approval for its Alzheimer’s disease drug, Leqembi. This decision not only marks a significant milestone for the treatment of Alzheimer’s but also sets a precedent for the review and potential approval of other therapies for the neurodegenerative disorder. Leqembi is an antibody that targets the buildup […]

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On June 22, 2023, the U.S. Food and Drug Administration (FDA) approved Elevidys, the first gene therapy for the treatment of pediatric patients aged 4 to 5 years with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene and are eligible for the therapy. This approval addresses an urgent medical need […]

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The U.S. Food and Drug Administration (FDA) has published a new draft guidance addressing the use of psychedelic drugs for potential medical treatment. This is the first FDA draft guidance that provides considerations to industry for designing clinical trials involving psychedelic drugs. Psychedelic drugs have gained interest for their therapeutic potential in recent years. They […]

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The U.S. Food and Drug Administration (FDA) has provided an update on various news and developments within the agency. One of the updates highlights the dangers of accidental exposure to nicotine-containing e-liquids found in vape products. The FDA reminds parents to keep these products away from children as they can cause injury and even death. […]

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The U.S. Food and Drug Administration (FDA) has announced updates to its proposal for a unified Human Foods Program (HFP) and a new model for the Office of Regulatory Affairs (ORA). The changes aim to enhance coordination, prevention, and response activities across the FDA and improve the agency’s ability to support public health goals. The […]

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The U.S. Food and Drug Administration (FDA) has released several updates and guidance documents to improve food safety, drug development, orthopedic implants, and consumer-friendly labeling. One of the updates includes new frequently asked questions and tools for industry regarding the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule. This rule aims to identify and […]

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The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have sent warning letters to six companies for illegally selling food products containing Delta-8 tetrahydrocannabinol (THC), also known as delta-8 THC. These products resemble traditional foods like chips, cookies, candy, gummies, or other snack items, and can be easily mistaken as such. […]

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