The Phase 1 dose-escalation trial enrolled 25 evaluable patients and was designed to determine the recommended dose of LYMPHIR
The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”
Under the deal, Uniphar will serve as LYMPHIR’s exclusive distribution partner across designated Western and Eastern European territories
The platform uses cutting-edge AI and automation to tackle the entire revenue cycle
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable
Enlicitide achieved all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
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