News

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 ...
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 ...
PipelineReview.com1h
GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency to expand use in adults 18 years and older
LONDON, UK I June 13, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted the company’s regulatory ...
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 ...
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 ...
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, ...
Elanco: Zenrelia Gets Positive Opinion From EU's Committee for Veterinary Medicinal Products
The positive opinion for Zenrelia, or ilunocitinib, opens the way for the product's marketing authorization in the European Union in the next 60 days. The company said it expects to launch Zenrelia ...
Consilium8d
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 ...