The U.S. Food and Drug Administration (FDA) is gearing up to approve a set of significant medications for the treatment of common and serious diseases such as certain types of cancer and migraines.

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Simultaneously, pharmaceutical companies and researchers are conducting or resuming clinical trials on a range of groundbreaking drugs for diseases that have been resistant to treatment for decades, such as Alzheimer’s and melanoma skin cancer.

According to empr, a series of decisions regarding the approval of these drugs is expected from the FDA in January 2024.

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The anticipated list of drugs to be approved or clinically tested in 2024 includes:

1. Stomach and Esophageal Cancer Treatment The FDA is expected to approve “Zolbetuximab” in January 2024 for the treatment of stomach and esophageal cancer. Zolbetuximab is a monoclonal IgG1 antibody that binds to CLDN18.2 on the surface of cancer cells in the stomach.
2. Skin Cancer Drug (Lymphocytic Cells) The FDA is expected to soon approve Lifileucel from Iovance for the treatment of advanced skin cancer. Lifileucel involves the use of tumor-infiltrating lymphocytes (TILs) extracted from tumor tissues, purified, expanded, and then re-infused into patients.

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1. Treatment for Infectious Molluscum Contagiosum “Perdazimer,” a topical antiviral gel releasing nitric oxide, is set to be approved for the treatment of infectious molluscum contagiosum in January 2024.
2. Acute Migraine Treatment The drug STS101, an intranasal powder containing DHE (dihydroergotamine), is expected to be approved for the treatment of acute migraines in early 2024.
3. Motion Sickness Prevention A nasal gel containing scopolamine (DPI-386 Nasal Gel) is expected to be released in January 2024 for the prevention of motion sickness.

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1. Myopia Treatment for Children The drug NVK002, a low-dose atropine 0.01%, is expected to be released in January 2024 for the treatment of myopia in children.
2. Alzheimer’s Drug for Trial in 2024 CuraSen Therapeutics plans to begin the first clinical trial on humans using the new drug CST-3056 for neurodegenerative diseases in the fourth quarter of 2024.
3. Treatment for Rare Cholestatic Liver Disease The investigational drug elafibranor is under priority review by the FDA for possible approval on June 10, 2024, for the treatment of rare cholestatic liver disease (PBC).