FDA extends review period for Incyte’s sNDA for ruxolitinib cream
Incyte noted that the latest move comes after the acceptance and priority review of its sNDA for the cream in December last year. The FDA has extended the
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.