STAT18h
Risk of aspiration during surgery added to GLP-1 drug labels
But we have some pretty good clues. Among the possibilities: Newly empowered Republicans could tweak the Medicare drug price ...
Spectral Medical Announces Third Quarter Results and Provides Corporate Update
Detailed price information for Spectral Medical Inc (EDT-T) from The Globe and Mail including charting and trades.
manilatimes7d
Spectral Medical Provides October Tigris Trial Update
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic ...
Longview News-Journal17d
KIND Announces FDA Granted Orphan Drug Designation (ODD) for AND017 in the Treatment of Sickle Cell Disease (SCD)
FDA Orphan Drug Designation (ODD) is granted to a drug or biological product to prevent, diagnose or treat a rare disease or condition that affects fewer than 200,000 people in the United States.
www.hks.harvard.edu18d
FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time
July 2024, Paper: "The Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies by supporting the ...
BioSpace19d
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company anticipates an ...
Investing20d
Envoy Medical gains AMA approval for implant codes
Envoy Medical is also developing the Acclaim® Cochlear Implant, which received FDA Breakthrough Device Designation in 2019 and is designed for severe to profound sensorineural hearing loss.
WWLP-22News20d
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
Acceptance of the company’s De Novo application follows FDA’s previous granting of Breakthrough Device Designation to DrugSorb-ATR, making it eligible for priority review. The Company ...