FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
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Sep 3
FDA Seeks Public Input to Advance Development of Botanical Drug Products
FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
- The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets.
- The EUA was also revised for Nitenpyram Tablets, the generic version of Capstar.
- Nitenpyram Tablets were initially authorized in June 2026 for treatment only.
- Capstar and Nitenpyram Tablets are available over the counter and come in two tablet sizes: 11.4 and 57 mg.
- Dosage of Capstar and Nitenpyram Tablets is based on a dog’s or cat’s weight.
- Capstar is sponsored by Sergeant’s Pet Care Products LLC of Omaha, Nebraska.
FDA Approves First Drug to Treat Alexander Disease
- FDA approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.
Sep 4
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
- The U.S. Food and Drug Administration granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for the treatment of adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
- The FDA also authorized the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with camizestrant.
- The accelerated approval was granted to AstraZeneca.
- At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have the ESR1 tumor mutation.
- After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have the ESR1 tumor mutation.
- Estimated median progression-free survival was 16 months in the Etcamah and CDK4/6 inhibitor arm and 9.2 months in the aromatase inhibitor and CDK4/6 inhibitor arm.