Vaxcyte gets FDA Breakthrough Therapy Designation for its pneumococcal disease treatment
Vaxcyte (NASDAQ:PCVX) announced that the U.S. FDA cleared the VAX-31 infant Investigational New Drug application and granted ...
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.
manilatimes9d
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 ...
F. Hoffmann-La Roche Ltd: Roche presents new data at CTAD, demonstrating its growing momentum in diagnostics for Alzheimer's disease
New data highlight the potential of the Roche Elecsys® Amyloid Plasma Panel and Elecsys ptau181 for ruling out Alzheimer's disease related amyloid pathology with very good accuracy.In the largest worl ...
Fox 44 Waco News14d
Invenio Imaging Receives FDA Breakthrough Device
SANTA CLARA , Calif., Oct. 30, 2024 /PRNewswire/ -- Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), announced today that the U.S Food and Drug ...
Longview News-Journal19d
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.edu20d
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 ...
BioSpace21d
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 ...
FierceBiotech22d
It's official: Michelle Tarver named director of the FDA's devices center
Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry ...
Fox 5 San Diego22d
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 ...