Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

Roche’s subcutaneous lunsumio receives CHMP backing for R/R follicular lymphoma

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent

Novo Nordisk's oral semaglutide gets EU approval for heart related treatment of type 2 diabet

EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine with near-zero GWP

Trixeo is the first pMDI medicine in AstraZeneca’s portfolio to use the near-zero GWP propellant

Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU

Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne