Spear wins approval for Fluorouracil cream 5%
The FDA approved the abbreviated new drug application based on Spear’s 318 patient study proving bioequivalence to Efudex for the precancerous actinic keratoses skin condition, the indication for
The US Food and Drug Administration (FDA) has issued traditional approval to Novartis for Fabhalta (iptacopan), to slow the decline of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.