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RSS FeedPosted by Michael Wonder on 12 Jan 2021
ObsEva provides update on Yselty (linzagolix) clinical development program
11 January 2021 - European Medicines Agency validates Yselty marketing authorisation application for uterine fibroids; US NDA Planned for 1H 2021. ...
Posted by Michael Wonder on 12 Jan 2021
Aerie Pharmaceuticals receives European Commission approval for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%
11 January 2021 - Aerie Pharmaceuticals today announced the European Commission has granted a marketing authorisation for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 11 Jan 2021
Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years
11 January 2021 - The European Commission has approved single-dose, oral Xofluza for the treatment of uncomplicated influenza in patients aged ...
Posted by Michael Wonder on 08 Jan 2021
Extra dose from vials of Comirnaty COVID-19 vaccine
8 January 2021 - EMA’s human medicines committee (CHMP) has recommended updating the Product Information for Comirnaty to clarify that ...
Posted by Michael Wonder on 06 Jan 2021
EMA recommends Moderna COVID-19 vaccine for authorisation in the EU
6 January 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease ...
Posted 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 23 Dec 2020
The European Commission approves Zogenix’s Fintempa (fenfluramine) oral solution for the treatment of seizures in Dravet syndrome
21 December 2020 - First EU market launch planned for Germany in Q1 2021. ...
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 22 Dec 2020
ViiV Healthcare announces the marketing authorisation of the first complete long-acting injectable HIV treatment in Europe
21 December 2020 - Marketing authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used ...
Posted by Michael Wonder on 22 Dec 2020
EMA organises a second public meeting about the new COVID-19 vaccines
22 December 2020 - EMA will organise a second public meeting on 8 January 2021 to inform European citizens about ...