Q4 2024 Earnings Call Transcript February 4, 2025 Merck & Co., Inc. misses on earnings expectations. Reported EPS is $1.72 ...
Aethlon Medical, Inc. (Nasdaq: AEMD ), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious ...
We recently compiled a list of the 10 Best ... of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated ...
The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational ... the efficacy of continued clinical trials. The foregoing list of risks and uncertainties is ...
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 Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).
Beckman Coulter receives US FDA breakthrough device designation for Alzheimer’s disease blood test
announced the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p-Tau217/ß-Amyloid 1-42 plasma ratio. This blood test is designed to aid ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
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