Browsing Tag
U.S. Food and Drug Administration
103 posts
Faster sepsis diagnosis? Accelerate Diagnostics’ WAVE System may hold the key
Accelerate Diagnostics seeks FDA clearance for its WAVE system, a rapid AST solution for serious infections. Will approval boost its struggling stock?
Danone faces quality concerns as FDA recalls International Delight coffee creamers
Danone North America has issued a voluntary recall of over 75,000 bottles of International Delight coffee creamer following…
CEL-SCI advances Multikine study with FDA nod, eyes non-dilutive funding for commercial push
CEL-SCI Corporation has taken a significant step toward commercializing its investigational Multikine neoadjuvant therapy, as the U.S. Food…
Guardant Health’s Shield blood test gains ADLT status, strengthening Medicare coverage for colorectal cancer screening
Guardant Health, Inc. has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid…
Charlotte’s Web and DeFloria advance Autism treatment with FDA Phase 2 approval
Charlotte’s Web Holdings, Inc., a recognized leader in hemp-derived wellness products, has announced a major development in the…
Mirum Pharmaceuticals gains FDA approval for Ctexli, the first drug for CTX
In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Ctexli (chenodiol) as the first…
Harmony Biosciences faces FDA setback for pitolisant in idiopathic hypersomnia
Harmony Biosciences Holdings, Inc. has encountered a regulatory hurdle in its efforts to expand the use of pitolisant…
Clarity Pharmaceuticals bags FDA fast track designation for prostate cancer candidate 67Cu-SAR-bisPSMA
Clarity Pharmaceuticals has achieved a major regulatory milestone with the United States Food and Drug Administration (FDA) granting…
FDA grants Breakthrough Therapy Designation to Lacutamab for Sézary Syndrome
Innate Pharma has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting Breakthrough…
Axsome Therapeutics wins big in Auvelity patent battle, stock jumps 14%
Axsome Therapeutics Inc. experienced a sharp rise in its share price, climbing 14% in premarket trading following the…