The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union
Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535
Merck has also decided to end the favezelimab clinical development program
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate
WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
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