To date, the Company has not received reports of adverse events related to this recall.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
The approval was based on data from three phase 3 trials that evaluated the efficacy and safety of upadacitinib in patients 12 years of age and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The approval was based on data from 3 pivotal phase 3 (ECZTRA 1-3) trials that evaluated the safety and efficacy of Adbry in 1934 adults with moderate to severe AD.
The approval was based on data from the phase 3 ADVANCE trial.
The phase 3 COSMOS study evaluated the efficacy and safety of guselkumab in 285 adults with active PsA who had an inadequate response to anti-tumor necrosis factors.
Zynrelef is a dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine and meloxicam.
Zavegepant is an investigational calcitonin gene-related peptide (CGRP) receptor antagonist.
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
The STEP 5 trial compared Wegovy to placebo in 304 adults who were overweight (BMI ≥27kg/m2) or obese (BMI ≥30kg/m2) over 2 years.
