News | March 25, 2022
CHMP recommends EU approval of Roche’s new combination treatment for large B-cell lymphoma
Recommendation is based on pivotal data from the phase III POLARIX study
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
The decision marks a pivotal moment for the Massachusetts-based biotech giant
KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients
AA, a chronic immune disease, can cause extensive and unpredictable hair loss
mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe
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