GSK announces EMA accepted for review the MAA for depemokimab
GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati ...
PMLiVE1d
Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...
Pharm Exec1d
Treating Disruptive Symptom’s in Crohn’s Patients: Q&A with Mark Genovese, MD
Mark Genovese: Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability, ...
The Financial Express1d
USFDA gives nod to Novo Nordisk’s Ozempic to reduce risk of kidney failure
Last month, the European Medicines Agency allowed Novo to add risk reduction for events related to kidney disease to the ...
GSK says asthma and nasal polyps therapy under EU review
GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here ...
ImmunityBio announces Anktiva MAA accepted for review by EMA
ImmunityBio (IBRX) announced the European Medicines Agency has accepted for review and begun assessing the marketing authorization application ...
GSK announces EMA to review the regulatory application of Shingrix
GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the regulatory application of a prefilled syringe ...
devdiscourse3d
EMA Shifts Digital Platform from X to Bluesky Amid Content Concerns
The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back ...
Buy3d
GSK shingles treatment application accepted for review in Europe
This European review of the prefilled syringe follows GSK's receipt of approval from the US Food & Drug Administration on January 8. GSK is also investigating submission of the new presentation to ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
FiercePharma6d
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 ...
Managed Healthcare Executive6d
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 ...