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Ezra Announces New FDA Clearance, Enhancing the Capabilities of Its Full-Body Scan Technology
February 20, 2025 09:00 ET
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Ezra
Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, announced new 510(k) clearance by the U.S. FDA.
Targeted Genomics Receives FDA Clearance for First Direct-to-Consumer Celiac Disease Genetic Health Risk Test
February 17, 2025 09:00 ET
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Targeted Genomics
IRVINE, Calif., Feb. 17, 2025 (GLOBE NEWSWIRE) -- Targeted Genomics LLC, a family owned genetic testing Company, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance...
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
January 07, 2025 08:00 ET
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Annovis Bio, Inc.
MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies...
AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market
December 19, 2024 17:05 ET
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AVITA Medical
AVITA Medical announces FDA clearance for Cohealyx, a new collagen-based dermal matrix, expanding its addressable market.
Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer
July 30, 2024 08:00 ET
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Processa Pharmaceuticals, Inc.
Open-label Phase 2 trial in breast cancer to begin this quarter Initial data expected mid-2025 HANOVER, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA)...
Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System
July 09, 2024 08:00 ET
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Curonix LLC
Curonix Receives the First Full-Body Peripheral Nerve Stimulator (PNS) FDA Clearance, including Craniofacial Pain Indication, for its Freedom® PNS System.
GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia
June 27, 2024 09:15 ET
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GT Biopharma, Inc.
GTB-3650 Phase 1 trial initiation expected in H2 2024; initial clinical data expected in H1 2025GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025GTB-5550...
BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
April 16, 2024 07:45 ET
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BioRestorative Therapies, Inc
— Amendment replaces saline injections with sham injections in the control group — MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or...
Biomerica Reports Second Quarter 2024 Financial Results
January 16, 2024 08:19 ET
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Biomerica, Inc.
Revenues excluding Covid test sales increased 10.3% for the second fiscal quarter of 2024 vs the second fiscal quarter of 2023.Loss per shares narrows to $0.09 per share from $0.12 per share...
Biomerica Received US FDA 510(k) Clearance for Their Hp Detect™ ELISA Test Product Designed to Detect the Presence of the H. pylori Bacteria That infects Approximately 35% of the U.S. Population
December 18, 2023 07:47 ET
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Biomerica, Inc.
Over 80% of gastric cancers are attributed to H. pylori bacterial infection Gastric cancer is the third most common cause of cancer related death in the world ...