April 19th 2024
Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
FDA Approves Aphexda for Use in Stem Cell Mobilization
September 12th 2023In clinical trials, Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal to enable stem cell transplantation for patients with multiple myeloma. It will have a list price 5,900 per vial, with most patients needing two vials for treatment.
X4 Pharmaceuticals Submits NDA of Mavorixafor for Rare Immunodeficiency Disease
September 5th 2023If approved, mavorixafor would be the first therapy to address the genetic defect that results in WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer.
AbbVie Submits Skyrizi to FDA, EMA for Ulcerative Colitis Indication
August 28th 2023The submissions to both the FDA and the EMA are supported by two phase 3 trials demonstrating Skyrizi achieved the primary endpoint of clinical remission. Skyrizi is already available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease.