Top-line results from a phase 3 trial of terlipressin (Mallinckrodt) found that the investigational treatment successfully reversed hepatorenal syndrome type 1 (HRS-1), the primary end point of the study.
Fast Track designation has been granted to nomacopan (formerly known as Coversin; Akari Therapeutics), an investigational treatment for hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in pediatric patients.
The FDA has granted Orphan Drug designation to an investigational therapy for the treatment of amyotrophic lateral sclerosis.
According to results from the ECLIPSE trial, treatment with guselkumab was found to be superior to secukinumab in adult patients with moderate-to-severe plaque psoriasis based on 90% or better improvement in patients’ Psoriasis Area and Severity Index score compared to baseline (PASI 90 response).
A Prescription Drug User Fee Act (PDUFA) target date of December 22, 2019 has been set for this tazarotene lotion application.
The FDA has granted Breakthrough Therapy designation to teplizumab (PRV-031; Provention Bio), for the prevention or delay of clinical T1D in those at risk of developing the disease.
Foamix Pharmaceuticals has submitted a New Drug Application (NDA) for FMX103, an investigational treatment for moderate to severe papulopustular rosacea in patients ≥18 years old. FMX103 is a topical foam formulation of minocycline. The NDA submission includes data from two phase 3 trials in which the efficacy and safety of the minocycline foam 1.5% was…
An Independent Data Monitoring Committee has recommended that SillaJen discontinue their phase 3 trial of Pexa-Vec (formerly JX-594) in patients with advanced hepatocellular carcinoma (HCC) following the evaluation of results from a formal pre-planned futility analysis.
