Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU
If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe
With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
Recommendation is based on pivotal data from the phase III POLARIX study
If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
A final decision regarding the approval of Ronapreve is expected from the European Commission shortly
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
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