Drug Approval | June 12, 2025
FDA approves Merck’s enflonsia for prevention of RSV in infants
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
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
Subscribe To Our Newsletter & Stay Updated
