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RSS FeedPosted by Michael Wonder on 09 Feb 2023
EMA confirms acceptance of application for AVT04, a proposed biosimilar to Stelara (ustekinumab)
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...
Posted by Michael Wonder on 08 Feb 2023
Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU
6 February 2023 - Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration and diabetic macular oedema is based ...
Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted a marketing authorisation application for lecanemab, an ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...
Posted by Michael Wonder on 12 Jan 2023
Eisai submits marketing authorisation application for lecanemab as treatment for early Alzheimer's disease in Europe
11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
Posted by Michael Wonder on 04 Jan 2023
Janssen submits marketing authorisation application to the European Medicines Agency seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 23 Dec 2022
Outlook Therapeutics announces validation of marketing authorisation application by the European Medicines Agency for ONS-5010 as a treatment for wet AMD
22 December 2022 - Submission follows the US FDA acceptance of the ONS-5010 BLA for wet AMD, with a PDUFA ...
Posted by Michael Wonder on 22 Dec 2022
Zynlonta (loncastuximab tesirine) approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma
21 December 2022 - Sobi and ADC Therapeutics today announced that the European Commission has granted conditional marketing authorisation for the ...
Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile ...
Posted by Michael Wonder on 20 Dec 2022
Albireo submits Bylvay Alagille syndrome regulatory filings to FDA and EMA
19 December 2022 - Gold standard Phase 3 ASSERT study supports supplementary filings in the US and EU. ...
Posted by Michael Wonder on 18 Dec 2022
Apellis submits marketing authorisation application to the EMA for pegcetacoplan for geographic atrophy
16 December 2022 - Apellis Pharmaceuticals today announced that the company has submitted a marketing authorisation application to the European Medicines ...