PhRMA tells FDA it strongly agrees with the potential benefits of artificial intelligence and machine learning, among three other public commenters vi...
Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria met their primary en...
Federal Register notice: FDA seeks comments on an information collection entitled Time and Extent Applications for Nonprescription Drug Products.
Federal Register notice: FDA makes available a draft guidance entitled QTc Information in Human Prescription Drug and Biological Product Labeling.
Aspen says it will start a Phase 1/2a trial of its ANPD001 cell therapy to treat Parkinsons disease under an FDA-approved IND.
FDA accepts for review a Vitaris/Mapi ANDA for GA Depot 40 mg as a once-monthly injection to treat relapsing multiple sclerosis.
A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.
A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations including exclusivity....
