Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
The company announced that its Phase III FENhance 1 and 2 studies both met their primary endpoints
The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone
The Phase III METEOROID study met its primary endpoint, with ENSPRYNG cutting the risk of a first relapse by 68% compared to placebo in adults and adolescents
IgAN is a rare, progressive kidney disease driven by abnormal IgA immune complexes that deposit in the kidneys
The study evaluated asundexian (50 mg), a once-daily oral anticoagulant candidate, versus placebo—both given alongside standard antiplatelet therapy
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
BioNTech will supply pumitamig, a PD-L1/VEGF-A bispecific antibody co-developed with Bristol Myers Squibb, while Boehringer Ingelheim will act as the regulatory sponsor of a Phase Ib/II study
Benefits were consistent across all key subgroups, including patients previously treated with covalent BTK inhibitors
Highlights Mirvetuximab-based regimen promise
The study is a global, randomized, double-blind, placebo-controlled trial testing GLM101 for phosphomannomutase 2 congenital disorder of glycosylation
The partnership aims to accelerate clinical trial timelines, boost data quality, and improve decision-making for sponsors worldwide
The data will be presented at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Munich, April 17-21
The trial also demonstrated significant improvements across multiple secondary endpoints
The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival
The trial, dubbed MALBEC, marks the first in a broader late-phase development push for MK-8748, with a second NVAMD study expected to begin later this year
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC)
The impact on Phase III trials is particularly significant, as these later-stage studies involve larger, committed patient populations and represent years of investment
Efzimfotase alfa is an investigational enzyme replacement therapy designed to reduce injection volume
Allergan also presented new insights on the growing population of patients on GLP-1 agonists for weight loss who are seeking aesthetic treatments
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