EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation

GSK secures European nod for easier-to-use Shingrix prefilled syringe

The current two-vial format requires healthcare professionals to mix a lyophilised antigen with a liquid adjuvant before administration

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

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