Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2024
EMA publishes agenda for 22-25 July 2024 CHMP meeting
22 July 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 20 Jul 2024
EMA accepts Deciphera’s marketing authorisation application for vimseltinib for treatment of patients with tenosynovial giant cell tumour
18 July 2024 - Application based on results from the MOTION Phase 3 study, in which vimseltinib demonstrated statistically significant and ...
Posted by Michael Wonder on 20 Jul 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA
19 July 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials. ...
Posted by Michael Wonder on 19 Jul 2024
Bristol Myers Squibb receives EMA validation of application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma
19 July 2024 - The Application is based on Phase 3 CheckMate-9DW trial results demonstrating improved survival with Opdivo plus ...
Posted by Michael Wonder on 19 Jul 2024
Bavarian Nordic receives EMA filing acceptance and validation of the MAA for its chikungunya vaccine
18 July 2024 - EMA will now initiate its centralised review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine. ...
Posted by Michael Wonder on 14 Jul 2024
Fresenius announces EMA validation of marketing authorisation application for denosumab biosimilar candidates
11 July 2024 - Fresenius, via its operating company Fresenius Kabi, announced that the EMA has accepted for review the company’s ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 10 Jul 2024
Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.
8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a ...
Posted by Michael Wonder on 10 Jul 2024
Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis
8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...
Posted by Michael Wonder on 06 Jul 2024
Submission of Nidlegy marketing authorisation application validated by EMA
4 July 2024 - The assessment period of the dossier by the authorities has started on 20 June. ...
Posted by Michael Wonder on 05 Jul 2024
Tagrisso with the addition of chemotherapy approved in the EU as new first-line treatment for patients with EGFR-mutated advanced lung cancer
5 July 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...