Opzelura Cream Approved for Nonsegmental Vitiligo
The approval was based on data from two phase 3 studies, which included patients 12 years of age and older with nonsegmental vitiligo who had depigmented areas.
All articles by Brian Park, PharmD
FDA Panel Votes in Favor of Gene Therapy for Cerebral Adrenoleukodystrophy
Eli-cel is an investigational one-time gene therapy designed to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells.
Testosterone Replacement Therapy Tlando Now Available
Tlando is supplied as 112.5mg of testosterone undecanoate capsules.
Bristol Myers Squibb Withdraws Luspatercept sBLA for NTD Beta Thalassemia
The application included data from the phase 2 BEYOND study.
Heart Failure Hospitalization Risk Compared With Empagliflozin vs Other Glucose-Lowering Txs
The EMPRISE study assessed the efficacy and safety of empagliflozin use in approximately 500,000 adults with type 2 diabetes.
FDA Extends Review Period for Fixed-Dose Combo Therapy for ALS
The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.
FDA to Review Data on Long-Term Use of Myfembree for Uterine Fibroids
The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.
Update on Availability of Byooviz, a Biosimilar to Lucentis
Byooviz (ranibizumab-nuna) is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.
FDA Extends Shelf Life of On-Demand Contraceptive Phexxi
Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Omburtamab Gets Priority Review for Neuroblastoma
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
