News

GSK applies to EU regulator for expanded use of RSV vaccine
GSK has applied to the European Medicines Agency to expand use of its respiratory syncytial virus (RSV) vaccine to adults ...
GSK says EU heath regulator reviewing expansion of RSV vaccine
GSK said on Friday the European Medicines Agency had accepted the drugmaker's application to expand the use of its ...
EU Drug Regulator Finds ‘Very Rare’ Ozempic Link to Vision Loss
Patients taking weight-loss medicines such as Novo Nordisk A/S’s Ozempic and Wegovy are at risk of developing an eye ...
Consilium9d
The pharma package: new EU rules on medicines
The purpose of the pharma package is to revise the current rules on medicines to make them more accessible to patients while ...
Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC
EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, ...
TMCnet36m
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy. PolTREG established Immuthera ( in Delaware to expand its prese ...
Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say
The European Medicines Agency's (EMA) safety committee (PRAC) has concluded its review of medicines containing semaglutide ...
Medical Dialogues3d
Diabetes and Weight-Loss Drug Semaglutide Linked to Rare Eye Condition: European Medical Agency
Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a ...
GSK says EU regulator reviewing expanded use of RSV vaccine
GSK said on Friday the European Medicines Agency had accepted the drugmaker's application to expand the use of its ...