This week, two new approvals for atopic dermatitis; Warnings around counterfeit HIV treatments; Some US indications for Zydelig are withdrawn; CDC pediatric flu vaccine study results; And an FDA warning against certain COVID-19 antibody tests.
Continued approval required further verification and description of clinical benefit in confirmatory trials.
The Company will be working with the FDA in the coming weeks to complete the label revision process.
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
Results showed an overall response rate of 84.8%.
Continued approval required further verification and description of clinical benefit in confirmatory trials.
The application could not be approved in its present form due to manufacturing deficiencies.
Besremi is a monopegylated, long-acting interferon, which exhibits its cellular effects in the bone marrow in polycythemia vera.
Review the October 2021 notable drug approvals.
The application is supported by data from several phase 2 studies.
