CSL's garadacimab, a first in class factor XIIa inhibitor, receives FDA and EMA filing acceptance

14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...

Read more →

FDA and EMA accept marstacimab regulatory submissions for the treatment of haemophilia A and B

11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...

Read more →

Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma

24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...

Read more →

Expanded access as a source of real‐world data: an overview of FDA and EMA approvals

22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...

Read more →

FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma

10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...

Read more →

Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients

8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...

Read more →

U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations

4 April 2018 - FDA priority review granted for U.S. new drug application. ...

Read more →

Ultragenyx announces recombinant human beta-glucuronidase biologics license application and marketing authorisation application filed and accepted for review; FDA grants priority review status

23 May 2017 - Ultragenyx today announced that a biologics license application submitted to the U.S. FDA and a marketing ...

Read more →