Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.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.
The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-reported outcomes tool ...
FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial visi...
Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapys use in all patients ...
GSK says a Phase 3 trial evaluating its Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer met its primary...
Novartis says it will seek FDA accelerated approval for atrasentan and its use in treating patients with IgA nephropathy.
FDA approves Impulse Dynamics Optimizer Smart Mini system for whole-body MRI-conditional use.
