FiercePharma1d
Seeking new social media horizons, EMA joins mass migration from X to Bluesky
As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...
NL Times1d
European Medicines Agency ditches Elon Musk’s X in favor of Bluesky
The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...
Daily1h
Sanofi Sarclisa approved in EU for newly diagnosed multiple myeloma
Paris: Following the adoption of a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products ...
TCTMD4d
European Medicines Agency Investigating GLP-1 Drugs and Eye Disease
A safety committee will review all evidence from trials and studies to shed more light on the potential risk of NAION.
Managed Healthcare Executive2d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
NL Times8d
European Medicines Agency to investigate link between Ozempic and rare eye disorder
The safety committee of the European Medicines Agency (EMA) will again study the medication, semaglutide, out of concerns ...
SMA1d
US, EU regulators to review higher-dose Spinraza for use in SMA
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...