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
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy
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
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