France-based Genfit launched NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH) powered by the company’s proprietary diagnostic technology, NIS4. The test is offered in the United States through Labcorp.
The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.
Meissa Vaccines’ intranasal live attenuated chimeric virus-based vaccine for SARS-CoV-2 (and its variants), which was cleared for Phase I trials, employs codon deoptimization to evoke a stronger-than-usual immune response.
Paris-based Ipsen secured Fast Track designation from the U.S. Food and Drug Administration for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.
Aptinyx Jumps Following Positive Phase II PTSD Study Results Published: Oct. 20, 2020 By Alex Keown BioSpace Shares of Aptinyx skyrocketed more than 75% after the company reported its mid-stage experimental treatment for post-traumatic stress disorder demonstrated clinically meaningful and statistically significant results that will set up a pivotal study next year. This morning, […]
Galapagos and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet the study’s primary endpoint in osteoarthritis knee repair.
Pfizer snagged Fast Track designation from the U.S. Food and Drug Administration for the company’s Duchenne muscular dystrophy (DMD) gene therapy treatment, PF-06939926.
ALX Oncology is partnering with pharma giant Merck to evaluate a combination of the CD47 inhibitor ALX148 with the blockbuster Keytruda as a potential treatment for patients with head and neck squamous cell carcinoma (HNSCC).
The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.