Blog
RSS FeedPosted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...
Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the ...
Posted by Michael Wonder on 21 Jan 2021
Italy ponders suing Pfizer for delays in coronavirus vaccine
21 January 2021 - Italy's coronavirus commissioner is pressing ahead with plans to take legal action against Pfizer after the ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 19 Jan 2021
Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines
19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...
Posted by Michael Wonder on 19 Jan 2021
The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
13 January 2021 - Few medicines are awaited as eagerly as COVID-19 vaccines. ...
Posted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 18 Jan 2021
Norway finds no direct link between elderly deaths and vaccine
19 January 2021 - Health authorities in Norway say there's no evidence of a direct link between the recent string ...
Posted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 14 Jan 2021
Johnson & Johnson could apply for EMA approval in February
14 January 2021 - US pharmaceutical company Johnson & Johnson may submit an official application for approval of its COVID-19 ...
Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...
Posted by Michael Wonder on 12 Jan 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
12 January 2020 - EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca ...