Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.
FDA approves an Amgen BLA for Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssens Stelara for multiple inflammatory diseases.
FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unapproved, adulterated, a...
FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.
FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynthen STING-agonist ant...
FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (fish oil triglyceride...
Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.
