BioCardia’s Pivotal Heart Failure Trial Enrolls First Patient
In BioCardia’s earlier CardiAMP-HF study, the composite endpoint of all-cause death, nonfatal major adverse cardiac events, and a validated...
PDS Biotech to Present New Cancer Therapy Data at SITC 2025
PDS Biotechnology’s National Cancer Institute collaborators will deliver three presentations at SITC 2025, headlined by a rapid oral on...
Breakthrough Oral Semaglutide Pill Shows Preclinical Promise
Preclinical data to be presented at ObesityWeek 2025 indicate that Rani Therapeutics’ oral semaglutide candidate (RT-116), delivered via the...
Ultragenyx Doses First Patient in New Angelman Syndrome Study
Ultragenyx has fully randomized 129 patients aged 4–17 with full maternal UBE3A gene deletion in the global Phase 3...
FDA Grants Orphan Drug Status for Gastric Cancer Treatment
Dewpoint Therapeutics secured FDA Orphan Drug Designation for DPTX3186, an oral condensate modulator targeting the Wnt/β-catenin pathway in gastric...
gMG Biologics Expand in Early Treatment, Newcomers Challenge
Retention on first-line biologics in generalized myasthenia gravis sits at 90% in US practice, with Alexion’s Ultomiris and argenx’s...
IN8BIO Expands INB-100 Phase 1 Trial to Ohio State Site
Previously reported readouts from the Phase 1 INB-100 program have shown no severe graft-versus-host disease, persistence of allogeneic γδ...
Medicus & Gorlin Alliance Seek Compassionate Use for Skinject
An interim analysis from Medicus Pharma’s randomized, double-blind, placebo-controlled Phase 2 study (SKNJCT-003) reported more than 60% clinical clearance...
Avalo Completes Enrollment for Phase 2 LOTUS Trial in HS
Avalo Therapeutics has fully enrolled its Phase 2 LOTUS study of AVTX-009 in hidradenitis suppurativa, randomizing roughly 250 adults...
Building Trust Through Transparency: Apellis Pharma’s Steph Viscomi on Lean TMF and Site Collaboration
At the Veeva R&D and Quality Summit, we spoke with Steph Viscomi, Head of TMF at Apellis Pharma, about...