GSK said on Friday the European Medicines Agency had accepted the drugmaker's application to expand the use of its ...

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

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, ...

FDA approves new Brukinsa tablet for five blood cancers, offering simpler dosing with the same safety and effectiveness as ...

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

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

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 ...

No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in ...

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

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 ...