Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

STADA & Bio-Thera bag European nod for Gotenfia

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure

Cidara hits target enrollment for Phase 3 flu trial ahead of peak season

CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions

Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment

This is the first and only subcutaneous immune checkpoint inhibitor available in Europe