Aimmune Therapeutics mistakingly pays a $2.5 million user fee with a BLA submission for AR101, an investigational biologic oral immunotherapy for trea...
FDA medical reviewers raise safety questions about Sanofis sotagliflozin that will be considered by the Endocrinologic and Metabolic Drugs Advisory Co...
FDA approves an Abbott PMA for the Amplatzer Piccolo Occluder, a tiny medical device that can be implanted in the smallest babies (weighing as little ...
Concerned that the partial government shutdown affecting FDA will have lingering effects over the course of the year impacting medical product reviews...
FDA accepts for review two Pfizer NDAs for tafamidis for treating transthyretin a meglumine salt formulation and a free acid formulation.
Despite safety concerns, a joint FDA advisory committee finds that there is a patient population with gout that exists for Takedas Uloric for its curr...
FDA commissioner Scott Gottlieb says the agency is monitoring whether branded biologic companies are taking any steps to undermine the fledgling biosi...
An FDA Bone, Reproductive and Urologic Drugs Advisory Committee plans to discuss an Amgen BLA for romosozumab, indicated for treating osteoporosis in ...