GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push

The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need

Moderna wins EU approval for first combined flu & COVID shot for adults 50+

The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states

EMA gives green light to warmer & simpler delivery rules for Wegovy injection

Novo Nordisk continues to position Wegovy as a cornerstone of its obesity treatment portfolio

EU nod to Rezurock for chronic GVHD in adults & teens

Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation

EMA moves to cut animal testing with “virtual control groups” in preclinical research

The approach, which could significantly reduce the number of rats used in certain dose-range finding studies

Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11

The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN

GSK seeks European nod for promising Hepatitis B therapy

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy

Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively

ImmunityBio scores first Asian approval for ANKTIVA in Macau

The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency