14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...