A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.
FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.Â
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning […]
FDA, in collaboration with the European Medicines Agency, has published 10 principles to help guide pharmaceutical companies using artificial intelligence to develop drug, biological, and medical devices.Â
FDA has released additional information on its “flexible approach” to regulating chemistry, manufacturing and control, or CMC, requirements for cell and gene therapies.Â
FDA accepted the new drug application for pimicotinib (ABSK021) as a systemic treatment for patients with tenosynovial giant cell tumor.Â
FDA has granted sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2 directed antibody-drug conjugate, a priority voucher via the agency’s Commissioner’s National Priority Voucher (CNPV) Pilot Program.Â
FDA has released a congressionally mandated report evaluating the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products.Â
FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer.Â
FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
