Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to PreludeDx's DCISionRT test, a risk assessment tool for ductal carcinoma in situ (DCIS), also known as Stage ...
Breakthrough Therapy Designation is generally granted to a drug when evidences suggest that ... You can see the complete list of today’s Zacks #1 Rank stocks here. In the past 90 days, estimates ...
GSK’227 is a novel antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. The Food and Drug Administration (FDA ...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to CergenX’s AI-powered tool for neonatal brain scans. The Irish startup will now be in line for prioritised ...
"We are honored to receive Breakthrough Device Designation from the U.S. FDA for our p‑Tau217/β-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more ...
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
These forward-looking statements include but are not limited to statements regarding the FDA’s grant of the Breakthrough Therapy Designation for ersodetug, the ersodetug Expanded Access Program ...