European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...
Alvotech announces EMA acceptance of MAA for AVT05
Alvotech (ALVO) and Advanz Pharma announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT05, ...
GlobalData on MSN6d
EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...
Yahoo Finance28d
Alnylam Submits Regulatory Application to the European Medicines Agency for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
We look forward to working closely with the EMA with the aim to bring this new treatment option to patients as soon as possible." The regulatory application is based on positive results from the ...
CBS News6d
European agency says 2024 is "virtually certain" to be warmest year on record
Climate scientists working at the European Union's Copernicus Climate ... According to its ERA5 dataset, the agency said it was "virtually certain" that the annual temperature for 2024 will ...
Catholic News Agency7d
European leaders pledge cooperation with Trump after historic comeback victory
European leaders expressed readiness to work ... Hannah Brockhaus is Catholic News Agency’s senior Vatican correspondent. After growing up in Omaha, Nebraska, she earned a degree in English ...
Channel NewsAsia Singapore19d
European agency offers support for struggling space sector
PARIS :The European Space Agency unveiled plans on Thursday to speed up payments to the space industry in the face of mounting job cuts, while imposing more scrutiny following cost overruns and ...
New York Daily News5d
50 European leaders assess how Trump will affect their fortunes and seek a common stance on Russia
BUDAPEST, Hungary (AP) — Around 50 European leaders on Thursday called for a stronger defense posture across the continent that no longer necessitates a fundamental dependence on Washington as ...
Reuters26d
European space chief says Europe must be able to compete globally
"It is really for industry to organise itself as it sees fit, but from a European Space Agency's point of view, I will always accompany industry's processes to be successful," Aschbacher said.
Chatham House5d
Trump and his growing number of European allies threaten the European project
As the US presidential election result became clear, European leaders followed a similar formula when congratulating President-elect Trump. They offered their congratulations, mentioned previous good ...
Muscular Dystrophy News22d
EMA agency continues to oppose renewing Translarna’s approval
The Committee for Medicinal Products for Human Use (CHMP) — part of the European Medicines Agency — again maintained its recommendation not to renew conditional marketing authorization for Translarna ...