Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample
VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells
The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing
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