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RSS FeedPosted by Michael Wonder on 05 Sep 2024
Prilenia’s pridopidine for Huntington’s disease accepted for European marketing authorisation review
3 September 2024 - Prilenia Therapeutics announces the acceptance of its European marketing authorisation application for pridopidine (45 mg orally ...
Posted by Michael Wonder on 19 Aug 2024
Bavarian Nordic submits data to EMA to extend Mpox/smallpox vaccine approval to adolescents
16 August 2024 - Interim results from clinical study show non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu type II variation application validated by EMA for patients with HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
19 August 2024 - Submission based on DESTINY-Breast06 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated ...
Posted by Michael Wonder on 16 Aug 2024
EMA confirms acceptance of marketing application for AVT06, a proposed biosimilar to Eylea (aflibercept)
15 August 2024 - The approvals process is anticipated to be completed in the third quarter of 2025. ...
Posted by Michael Wonder on 16 Aug 2024
KalVista announces validation of marketing authorisation application by the EMA for sebetralstat for hereditary angioedema
15 August 2024 - KalVista Pharmaceuticals today announced that the EMA has validated the submission of a marketing authorisation application for ...
Posted by Michael Wonder on 01 Aug 2024
BioNet’s recombinant pertussis vaccine submitted to EMA
31 July 2024 - BioNet Europe has announced the submission of a centralised marketing authorisation application to the EMA for its ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
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 ...