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RSS FeedPosted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application ...
Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...
Posted by Michael Wonder on 30 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2 mg for the treatment of type 2 diabetes mellitus
29 December 2020 - Novo Nordisk today announced the submission of a label extension application to the EMA for the existing ...
Posted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 29 Dec 2020
Janssen submits European marketing authorisation application for amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
28 December 2020 - If approved, amivantamab will be the first-ever treatment specifically targeting EGFR exon 20 insertion mutations in the ...
Posted by Michael Wonder on 22 Dec 2020
Amgen submits sotorasib marketing authorisation application to the European Medicines Agency
22 December 2020 - Application is for patients with previously treated non-small cell lung cancer with the KRAS G12C mutation. ...
Posted by Michael Wonder on 18 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2.4 mg for weight management
18 December 2020 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for subcutaneous semaglutide ...
Posted by Michael Wonder on 17 Dec 2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
17 December 2020 - Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation ...
Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 07 Dec 2020
Janssen seeks EU approval for twice yearly schizophrenia treatment
7 December 2020 - Janssen has submitted a marketing authorisation extension application to the EMA for paliperidone palmitate six monthly ...
Posted by Michael Wonder on 01 Dec 2020
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
1 December 2020 - EMA has received an application for conditional marketing authorisation for a COVID-19 mRNA vaccine by Moderna Biotech. ...