AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older. The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the…
Janssen presents new safety data for Stelara in older patients
Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…
Phase 3 Tremfya results are promising for plaque psoriasis and psoriatic arthritis
Johnson & Johnson’s (NYSE:JNJ) pharmaceutical subsidiary Janssen has announced that its Tremfya (guselkumab) selective interleukin (IL)-23 inhibitor therapy led to durable, complete skin clearance in the majority of adults with moderate-to-severe plaque psoriasis (PsO) for up to five years. The drug also showed substantial efficacy in treating active psoriatic arthritis (PsA) for up to one…