Valneva lifts EMA’s temporary restriction on use of chikungunya vaccine IXCHIQ in elderly

The agency concluded that for people of all ages, IXCHI should be administered when there is a significant risk of chikungunya infection

FDA approves Bravecto Quantum from Merck Animal Health

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials

EMA and HMA to strengthen Anti-D Immunoglobulin supply chain

These medicines are essential in preventing RhD immunisation during pregnancy

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone

Glaukos receives EU MDR certification for iStent infinite

The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME

Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia

BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations