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
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
Merck KGaA, Darmstadt, Germany announced the presentation of new oncology data across more than 12 tumor types at ASCO 2025
Enpatoran is a potential first-in-class oral therapy for CLE and SLE that is thought to selectively block the activation of Toll-like receptors (TLR)7 and TLR8
Merck Wilmington Biotech will serve as a launch and commercial production facility and the future U.S. home for KEYTRUDA
Planned acquisition will strengthen the presence of Merck Healthcare in the United States and expand reach of SpringWorks’ therapeutic innovations to more patients with rare tumors worldwide
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
Collaboration combines data, identity capture and Web 3.0 crypto technologies to enhance product safety, traceability, and data integrity for AI systems
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