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.
FDA Issues Complete Response for Avasopasem for Severe Oral Mucositis
August 10th 2023Avasopasem was under review to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The FDA has indicted that an additional trial would be needed to show safety and effectiveness of avasopasem.