March 19, 2024
TOPLINE: In middle-aged men at high risk for Alzheimer’s disease (AD), higher pancreatic fat is linked to lower cognition and brain volumes. METHODOLOGY: Obesity is a […]
March 19, 2024
Adding an immune checkpoint inhibitor to platinum-based chemotherapy resulted in a more than 1-year gain in median overall survival for women with primary advanced or recurrent […]
March 19, 2024
TOPLINE: Depression is linked to a significantly increased risk for cardiovascular disease (CVD), particularly in women, new data from a large retrospective cohort study show. Researchers […]
March 19, 2024
Reformulating Drug Products That Contain Carbomers Manufactured With Benzene Guidance 12/28/2023 NDA (new drugs), ANDA (generic drugs), DMF (drug master files), Drug Product, CGMP, Compendial Standards, […]
March 18, 2024
No. DrugName Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)Press ReleaseDrug Trials Snapshot 58. Elzonris […]
March 18, 2024
What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering […]
March 18, 2024
Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]
March 18, 2024
Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]
March 18, 2024
Adding pembrolizumab (Keytruda) to concurrent chemoradiotherapy in patients with high-risk locally advanced cervical cancer does not harm quality of life, according to patient-reported outcome analyses from […]