Phase III
Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.
Lysogene’s investigational gene therapy LYS-SAF302 failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.
Pfizer and BioNTech reported positive data Friday from their Omicron BA.4/BA.5-adapted bivalent booster. This followed a similar announcement by Moderna Monday.
Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.
Astellas’ Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.
Huntington’s disease might just top the list of intractable neurodegenerative diseases. BioSpace spoke with the field’s foremost experts about the challenges and how to overcome them.
Tricida, Inc. is reducing its headcount by around 57% to improve its financial standing after its lead candidate failed in a Phase III trial, the company revealed in its third-quarter financial results.
When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise - including Biogen and Eisai.
RSV, influenza, COVID-19 and monkeypox have dominated vaccine discussions this year, but vaccines are also being developed for a host of other infectious diseases.
Topline results from the Phase III SUMMIT trial showed Satsuma Pharmaceuticals’ migraine candidate STS101 did not meet its primary efficacy endpoint.
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