Blog
RSS FeedPosted by Michael Wonder on 25 Jun 2024
Jemperli (dostarlimab) plus chemotherapy application accepted for review by the EMA to expand use to all patients with primary advanced or recurrent endometrial cancer
24 June 2024 - Regulatory submission supported by statistically significant and clinically meaningful progression-free and overall survival data from Part 1 ...
Posted by Michael Wonder on 02 Jun 2024
Takeda receives positive CHMP opinion for recombinant ADAMTS13 (rADAMTS13) in congenital thrombotic thrombocytopenic purpura
31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...
Posted by Michael Wonder on 21 Dec 2023
Janssen submits marketing authorisation application to the EMA seeking approval of lazertinib, in combination with Rybrevant (amivantamab), for the first-line treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking ...
Posted by Michael Wonder on 15 Dec 2023
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 ...
Posted by Michael Wonder on 12 Dec 2023
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 ...
Posted by Michael Wonder on 06 Sep 2023
Arcturus Therapeutics and CSL announce European Medicines Agency validates marketing authorisation application for ARCT-154 vaccine to prevent COVID-19
5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...
Posted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 24 Aug 2021
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; ...
Posted by Michael Wonder on 08 Jan 2021
Extra dose from vials of Comirnaty COVID-19 vaccine
8 January 2021 - EMA’s human medicines committee (CHMP) has recommended updating the Product Information for Comirnaty to clarify that ...
Posted by Michael Wonder on 31 Mar 2020
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 ...
Posted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP. ...
Posted by Michael Wonder on 25 Jul 2019
Astellas announces acceptance by the EMA of a variation application for regulatory review for use of Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer
24 July 2019 - Astellas Pharma announced the acceptance by the EMA of a Type II variation application for regulatory review ...
Posted by Michael Wonder on 10 Jul 2019
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 ...
Posted by Michael Wonder on 26 Jun 2019
Pacira BioSciences announces validation of Exparel marketing authorisation application from European Medicines Agency
25 June 2019 - Advances global expansion strategy to minimise post-surgical opioid use worldwide. ...
Posted by Michael Wonder on 01 Mar 2019
Astellas announces acceptance of Xospata (gilteritinib) for regulatory review by the European Medicines Agency
28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application for the oral once-daily ...