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 identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing, registrational-intent, phase IIb trial in ...
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
Breakthrough Therapy Designation is intended to expedite ... This designation provides Denali with more intensive FDA guidance, including involvement of senior reviewers, and eligibility for ...
Breakthrough Therapy Designation is generally granted to ... This designation will provide Denali with more intensive FDA guidance, including involvement of senior reviewers, and eligibility ...
Findings showed patients treated with brelovitug achieved 100% virologic response on all dosing arms. The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ...
"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 ...
Detailed price information for Denali Therapeutics Inc (DNLI-Q) from The Globe and Mail including charting and trades.