for the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older inadequately controlled with H1 antihistamine treatment. The original sBLA was ...
Juvenile idiopathic arthritis (JIA) is a form of arthritis in children. Arthritis causes joint swelling (inflammation) and joint stiffness. JIA is arthritis that affects 1 or more joints for at least ...
Chronic kidney disease (CKD) is defined as a progressive loss of renal function that lasts for more than 3 months, and is classified according to the degree of kidney damage – measured by the ...
Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive ...
TA38 27 March 2002 27 March 2002 Guidance on the use of trastuzumab for the treatment of advanced breast cancer TA34 15 March 2002 15 March 2002 Guidance on the use of fludarabine for B-cell chronic ...