the Digital Medicine Society (DiMe) released findings from a digital health industry needs assessment to identify 1) the drivers of successful digital health product development and adoption, and 2) the regulatory policy needed to facilitate these drivers.
Tag Archive for: U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration has selected James “Jim” Jones, a 30-year veteran of the Environmental Protection Agency (EPA), to direct its food division as part of a broader reorganization, the agency said on Wednesday.
The U.S. Food and Drug Administration on Monday approved Pfizer’s (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies.
The FDA has established a voluntary pilot program intended to address the risks when targeted cancer treatments are approved without a companion diagnostic.
The FDA has expanded the label of Regeneron’s blockbuster eye therapy Eylea (aflibercept), allowing the administration of a higher 8-mg dose at up to 16-week intervals, the company announced Friday.
Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns.
The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s drug Leqembi, should it win traditional U.S. approval as expected by July 6.
Thursday, the FDA denied Intercept Pharmaceuticals’ application for its obeticholic acid tablets, which the New Jersey biopharma was proposing to treat patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.
Wednesday, the FDA denied Aldeyra Therapeutics’ application for ADX-2191 (methotrexate injection, USP), which the Massachusetts biotech was proposing to treat the rare eye cancer primary vitreoretinal lymphoma.
The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly and partner Boehringer Ingelheim’s drugs Jardiance and Synjardy to treat type 2 diabetes in children.
