A recent study reveals that only 23.6% of examined JCOG trials completed within their planned accrual period, highlighting a significant challenge in clinical trial management.

The Phase III ATTAIN trial is evaluating etirinotecan pegol versus physician's choice of treatment for advanced breast cancer patients with stable, treated brain metastases.

Angitia Biopharmaceuticals has initiated a Phase 2 clinical trial (ARTEMIS) of AGA2118 for treating postmenopausal osteoporosis.

NeuroPace has submitted three-year safety and effectiveness data from its Post-Approval Study (PAS) of the RNS System to the FDA.

A novel compound, SNP-630, and its active metabolites demonstrate therapeutic potential against MASH in preclinical mouse models by reducing liver fat and fibrosis.

A phase III trial in China found that adding thoracic radiotherapy to EGFR-TKI treatment significantly improved progression-free survival in EGFR-mutated, oligo-organ metastatic NSCLC.

Public Citizen has formally requested the FDA to investigate the clinical trials of lecanemab (Leqembi) and donanemab (Kisunla) for Alzheimer's disease, citing concerns over trial conduct.

Coya Therapeutics reports that five of eight planned patients have been enrolled in a Phase 1 study evaluating low-dose IL-2 and CTLA4-Ig combination for frontotemporal dementia (FTD).

Brexucabtagene autoleucel demonstrated a 91% objective response rate in patients with relapsed or refractory mantle cell lymphoma who were BTK inhibitor-naive.

Curacle presented Phase 2a trial results for CU06 at the Asia Retina Congress, revealing improvements in visual acuity for DME patients.

Nerandomilast (BI 1015550) met the primary endpoint in the Phase 3 FIBRONEER-IPF trial, demonstrating improved lung function in IPF patients.

An AI-based pathology tool, AIM-MASH, has been clinically validated for scoring key histological features of metabolic dysfunction-associated steatohepatitis (MASH).

The Taiwan Food and Drug Administration (TFDA) has approved NEFECON® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression.

Solengepras, a novel GPR6 inverse agonist, significantly reduced OFF time in Parkinson's patients in a Phase 2 trial, demonstrating a potential non-dopaminergic treatment approach.

The Data and Safety Monitoring Board (DSMB) has approved Ocugen's OCU410ST to advance to Phase 2 clinical trials for Stargardt disease.

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited oral antibacterial options. • Orlynvah is the first FDA-approved product for Iterum Therapeutics and the first oral penem antibiotic approved in the U.S. for uUTIs. • This approval provides a new treatment option to combat antimicrobial resistance and addresses the unmet need for difficult-to-treat uUTIs. • Iterum Therapeutics plans to pursue a strategic transaction for Orlynvah to maximize value for stakeholders following the FDA approval.

RemeGen's marketing application for Taicercept (telitacicept) for generalized myasthenia gravis (gMG) treatment has been accepted by China's Center for Drug Evaluation.

Chugai Pharmaceutical has filed for approval of Tecentriq (atezolizumab) in Japan for relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL).

OncoResponse announced positive Phase 1 trial results for OR502, a novel anti-LILRB2 antibody, at the SITC conference.

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited oral antibacterial options. • Orlynvah is the first approved indication for Iterum Therapeutics and the first oral penem antibiotic approved in the U.S., offering a novel treatment option. • The approval targets uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, addressing antimicrobial resistance challenges. • Iterum Therapeutics is seeking a strategic transaction for Orlynvah to maximize stakeholder value following this FDA approval.