FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
07 janv. 2025 08h00 HE
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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
19 déc. 2024 17h05 HE
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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
30 juil. 2024 08h00 HE
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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
09 juil. 2024 08h00 HE
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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
27 juin 2024 09h15 HE
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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
16 avr. 2024 07h45 HE
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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
16 janv. 2024 08h19 HE
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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
18 déc. 2023 07h47 HE
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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 ...
Sleepiz AG Lands FDA 510(k) Clearance for Contactless Remote Patient Monitoring Device Measuring Vital Signs
10 oct. 2023 08h00 HE
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Sleepiz USA LLC
MINNEAPOLIS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Sleepiz, a Zurich-based medical technology company providing contactless bedside patient monitoring, today announces the FDA Class II 510(k) clearance...
Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials
24 août 2023 09h00 HE
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BIOXYTRAN, INC.
First Antiviral Drug in Glycovirology BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral...