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Results For "Merck-Research-Laboratories"

128 News Found

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients
Drug Approval | August 18, 2025

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo


Merck to initiate Phase 3 trials for investigational once-monthly HIV prevention pill
News | July 14, 2025

Merck to initiate Phase 3 trials for investigational once-monthly HIV prevention pill

In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally


FDA accepts new drug application for Merck’s Doravirine/Islatravir
Drug Approval | July 11, 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act


Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025
Clinical Trials | July 09, 2025

Merck to present new research data across its HIV prevention and treatment pipeline at IAS 2025

Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Clinical Trials | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy


FDA approves Merck’s enflonsia for prevention of RSV in infants
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


Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC
Clinical Trials | June 02, 2025

Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC

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


Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer
News | May 31, 2025

Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer

Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

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


European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease
Drug Approval | March 27, 2025

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults