FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.
Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drugs and biologics.
FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.
FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two ...
FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive ai...
FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathol...
FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ...
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme elevations were unco...
