BioSpace News Archive

Policy

IceCure’s ProSense® Deepens Regulatory Approval in India

IceCure Medical Ltd. (NASDAQ: ICCM) (“IceCure”, “IceCure Medical” or the “Company”) today announced that the Central Drugs Standard Control Organization (“CDSCO”) in India has granted approval for the ProSense® system based on the CDSCO’s updated regulatory requirements.

November 29, 2023
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4 min read
Biotech Beach

US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

BiVACOR, Inc. today announced the United States Food and Drug Administration (FDA) has provided approval for The BiVACOR Total Artificial Heart (BTAH) to commence an investigational device exemption (IDE) for the first-in-human Early Feasibility Study (EFS).

November 29, 2023
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4 min read
Bio NC

ArrivoBio Raises $45M in Series B Financing to Advance Pipeline

Arrivo BioVentures today announced the closing of an oversubscribed Series B preferred financing round, totaling $100M.

November 29, 2023
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3 min read
Business

Processa Pharmaceuticals Issues Letter to Shareholders Highlighting Corporate Strategy, Drug Pipeline, and Outlook

Processa Pharmaceuticals, Inc. announces that CEO George Ng has issued a letter to shareholders.

November 29, 2023
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9 min read
FDA

Zilia Receives FDA Clearance for its Zilia Ocular FC Retinal Camera

Zilia, a medical technology company specializing in the non-invasive assessment of ocular biomarkers, announced today a significant advancement in the deployment of its groundbreaking technology set to transform the diagnosis and management of ocular diseases.

November 29, 2023
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1 min read
Drug Development

Panbela Announces 2nd Independent Safety Review of the ASPIRE Registration Clinical Trial: Recommended Continuation with no Trial Modification

Panbela Therapeutics, Inc. announces that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients.

November 29, 2023
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6 min read
Genetown

Enveric Biosciences Receives Notice of Allowance from USPTO for Development of Glycosylated Psilocybin Derivatives

Enveric Biosciences today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application pertaining to its EVM301 Series of molecules being developed as potential treatments for mental health disorders.

November 29, 2023
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5 min read
NurExone Biologic Extends Spinal Cord Injury Therapy Portfolio With New RNA Sequences Promoting Healing and Regeneration

NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”) has recently unveiled laboratory tests of its secondary two proprietary sequences, representing a significant advancement in the treatment of spinal cord injuries.

November 29, 2023
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5 min read
Drug Development

Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera’s Next Generation Oral Peptide Platform

Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) reported today interim data from an ongoing Phase 1 study designed to assess and compare the pharmacokinetic (PK) and early pharmacodynamic (PD) profile of current and several next generation compositions of its oral peptide platform (NCT05965167).

November 29, 2023
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7 min read
AI Innovation for automated Detection and Classification of osteoporotic Fractures of the Spine in CT Scans - ImageBiopsy Lab launches IB Lab FLAMINGO

ImageBiopsy Lab, a pioneer in medical imaging, introduces IB Lab FLAMINGO at this year’s RSNA conference.

November 29, 2023
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3 min read