On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
9/3/2024
/ Biologics ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Vaccinations
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s...more
Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing...more
Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal...more