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 ...
New medical devices deemed "breakthrough" by the FDA are no longer automatically eligible for extra Medicare payments.
Zolbetuximab has been hailed as one of the most consequential additions to gastric cancer therapy in a generation. The monoclonal antibody targets claudin 18.2, a protein that sits on the surface of ...
Engineered 20-nanometer surface architecture on Innovasis' HA-coated titanium implants was reviewed and cleared under the FDA's Nanotechnology Guidance, confirming nanoscale surface features with ...
Glucommander Pediatrics received FDA Breakthrough Device Designation for IV insulin dosing in hospitalized children younger than 2 years, but remains uncleared. Glytec announced that the FDA has ...
Glytec, creator of the FDA-cleared Glucommander glycemic management software, revealed that the agency granted breakthrough status for Glucommander Pediatrics. The proposed insulin dosing ...
GLM101 received FDA Breakthrough Therapy designation for PMM2-CDG; primary endpoint data from the phase 2b POLAR trial evaluating ataxia via ICARS are expected in Q4 2026. The Food and Drug ...
SAN DIEGO--(BUSINESS WIRE)--Alume Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bevonescein for use as an ...
Pre-commercial precision oncology firms often face steep financial trade-offs, where absent return on invested capital/ROIC and negative operating cash flows are the price of admission for long-term ...
Revolution Medicines (RVMD) recently received good news, as the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to its drug RASONQUE, which is expected to accelerate ...
Three months ago, Nuvectis Pharma (NASDAQ: NVCT) was an oncology developer anchored by a single early-stage program. Today it holds ex-China rights to the world's first approved once-daily oral Factor ...
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