CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
68% of children on a higher dose of Dupixent achieved histological disease remission at week 16
Sotatercept demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy
Study achieves primary endpoint of radiographic progression-free survival
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial
The Phase 3 SOLO-1 trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations receiving LYNPARZA were alive at seven years versus 47% of placebo patients
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
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