FDA issued a final guidance, “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.”
FDA issued a draft guidance, “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.”
FDA issued a draft guidance, “Tissue Agnostic Drug Development in Oncology.”
The findings from the 2022 National Youth Tobacco Survey on e-cigarette use among U.S. youth, published by FDA and CDC in Morbidity & Mortality Weekly Report, show that youth use of e-cigarettes remains high, with 2.5 million (9.4%) of the nation’s middle and high school students reporting current e-cigarette use.
FDA has granted accelerated approval to Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
The FDA Oncologic Drugs Advisory Committee voted down three problematic indications of cancer drugs, two of which got on the market under the agency’s accelerated approval program.
Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say. Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the […]
FDA has granted regular approval to Retevmo (selpercatinib) adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
FDA has approved Pedmark to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.
FDA has issued a safety alert informing patients and providers about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare.
