August 4, 2023

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support […]

admin Health 0 1 min read
June 12, 2023

Presentation of longer-term data for Tecvayli showing a duration of response of 22 months in patients with r/r multiple myeloma – Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/II MajesTEC-1 study showing the sustained efficacy and safety of Tecvayli (teclistamab-cqyv) in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed and previously received treatment with three or more prior lines of therapy. These results showed that nearly […]

admin Health 0 4 min read
October 24, 2021

Janssen submits application seeking FDA approval of Stelara for the treatment of pediatric patients with juvenile psoriatic arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and […]

admin Health 0 37 sec read
May 30, 2021

MHRA approves Ad26.COV2-S [recombinant] for active immunisation against COVID-19 within the United Kingdom – Janssen

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]

admin Health 0 27 sec read

Recent Posts

Meta

Categories

Archives

Recent Comments