Jenna Payesko

This is the first and only therapy indicated in the US to help prevent angioedema attacks in pediatric patients as young as 6 years old.

This minimally invasive procedure provides additional options for the patient population suffering with sacral insufficiency fractures.

Daily upadacitinib monotherapy 15 mg/30 mg met both primary endpoints with 52%/56% of methotrexate patients achieving ACR50 at week 12 and 48%/50% achieving clinical remission at week 24.

The committee recommends the approval of baricitinib 2-mg, but not 4-mg; this comes a year after baricitinib was rejected by the FDA.

Upadacitinib (15 mg, once-daily) met both primary endpoints, with 71% of patients achieving ACR20 and 29% achieving clinical remission at week 12.

The monotherapy resulted in LDA by week 14 in both the 15 mg (45%) and 30 mg (53%) groups.

If approved, this will be the first and only topical lotion that contains a unique combination formula.

Actemra/RoActemra has potential to change how GCA is treated.

The drug is the first and only fully-human antagonist showing sustained skin clearance rates at 5 years.

The study showed positive results in a difficult-to-treat patient population.