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  1. www.fda.gov › drugs › resources-information-approved-drugsFDA grants accelerated approval to selpercatinib

    4 天前 · On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with RET-altered ...

  2. www.fda.gov › news-events › press-announcementsFDA Approves First Interchangeable Biosimilar for Two Rare ...

    5 天前 · May 28, 2024. Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is...

  3. www.fda.gov › regulatory-information › search-fda-guidancePlatform Technology Designation Program for Drug Development ...

    5 天前 · This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C 16 Act). 2 This ...

  4. www.fda.gov › inspections-compliance-enforcement-andAruba Aloe Balm N.V. - 674911 - 05/13/2024 | FDA

    5 天前 · United States. Warning Letter. May 13, 2024. Dear Mr. Veel: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Aruba Aloe Balm N.V., FEI 3004117460, at ...

  5. www.fda.gov › inspections-compliance-enforcement-andOstar Beauty Sci-Tech Co Ltd. - 667871 - 12/04/2023 | FDA

    5 天前 · CMS: #667871. December 04, 2023. Dear Mr. Carey Har: The United States Food and Drug Administration (FDA) has learned that your firm is marketing the following products in the United States ...

  6. www.fda.gov › news-events › press-announcementsFDA Roundup: May 28, 2024 | FDA

    5 天前 · May 28, 2024. Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA announced it had opened a new period for ...

  7. www.fda.gov › inspections-compliance-enforcement-andWard Smelling Salts - 672166 - 04/30/2024 | FDA

    5 天前 · WARNING LETTER. April 30, 2024. RE: 672166. Dear Mr. Inglot: This letter concerns your firm’s distribution of over-the-counter (OTC) stimulant drug products. The U.S. Food and Drug ...