GSK has applied to the European Medicines Agency to expand use of its respiratory syncytial virus (RSV) vaccine to adults ...

GSK (LSE:GSK) announced that the European Medicines Agency accepted its regulatory application to expand the use of its RSV ...

A comprehensive analysis conducted by public health experts at Novartis Romania reveals that Romanian patients may wait, on ...

Confirms Single Phase 3 Immuno-Bridging Trial Sufficient to Evaluate Efficacy and to Support a Marketing Authorization ...

or diagnosis of life-threatening or chronically debilitating diseases that affect no more than two in 10,000 people in the European Union (EU) and for which no satisfactory therapy is available.

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment options The multiple regulatory ...

The European Medicines Agency has identified a rare eye condition risk linked to Novo Nordisk’s semaglutide drugs.

The purpose of the pharma package is to revise the current rules on medicines to make them more accessible to patients while ...

to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA ...

Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a ...

Advert Previous studies linked the drug to a rare eye condition known as non-arteritic anterior ischemic optic neuropathy ...

The latest update atopic dermatitis guidelines include the new approval of lebrikizumab and the expanded use of baricitinib ...