Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial

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

Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies

DBT, BIRAC and CEPI renew cooperation agreement for vaccine development

DBT and BIRAC have partnered with CEPI since 2019, for cooperation on vaccine development for diseases of epidemic potential

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data