Category: application

  • Novo Nordisk Receives the US FDA’s Refusal to File Letter for Semaglutide to Treat T2D

    Shots: The US FDA has issued refusal to file a letter covering the label expansion application for semaglutide (2.0mg/qw) for T2D, which was submitted on Jan 20, 2021 The US FDA has requested additional information including data relating to new manufacturing site Novo Nordisk plans to resubmit the application to FDA in Q2’21 Click here ­to­ […]

  • BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

    Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability […]