Potentially accelerates development, assessment, and review for approval by FDA Sepsis impacts about 1.7 million U.S. adults ...
The designation gives HeartBeam prioritized FDA interaction as it prepares a pivotal study of its 3D ECG technology for assessing suspected heart attacks outside traditional medical settings. Key ...
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Nutromics' microneedle wearable patch for vancomycin therapeutic drug monitoring. Approximately 2.9 million ...
Add Yahoo as a preferred source to see more of our stories on Google. Hyperglycaemia is common among ill newborns and premature infants and is associated with poor outcomes in this patient group.
Please provide your email address to receive an email when new articles are posted on . The drug, a formulation of LSD, previously received breakthrough therapy designation related to generalized ...
New medical devices deemed "breakthrough" by the FDA are no longer automatically eligible for extra Medicare payments.
Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class adjunct in the real-time intraoperative visualization of nerves during head and neck ...
LOS ANGELES, Sept. 14, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company focused on the development of ...
Revolution Medicines received breakthrough therapy designation from the Food and Drug Administration for its treatment of pancreatic cancer. The designation is for Rasonque to treat metastatic ...
The Breakthrough Therapy Designation is based on data from the open-label, multicenter Phase 1/2 RMC-GI-102 trial of RASONQUE in combination with GnP in patients with treatment-naïve, RAS-mutant ...
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