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RSS FeedPosted by Michael Wonder on 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
Posted by Michael Wonder on 14 Feb 2024
Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the US and EU
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...
Posted by Michael Wonder on 04 Jan 2024
Applied Therapeutics announces MAA validation and NDA submission of govorestat (AT-007) for treatment of classic galactosaemia
3 January 2024 - Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term ...
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 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...