FDA posts a draft guidance on biosimilar development formal meetings between the agency and sponsors.
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Federal Register notice: FDA makes available a draft guidance entitled QTc Information in Human Prescription Drug and Biological Product Labeling.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.
