Expanded Access

HyBryte™ Expanded Treatment Trial in Cutaneous T-Cell Lymphoma Opens Enrollment


Study Supported by $2.6 Million FDA Orphan Products Development Grant Excerpt from the Press Release: PRINCETON, N.J., Aug. 10, 2023 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment…

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Solid Biosciences and Phlox Therapeutics Announce Strategic Research Collaboration Focused on Accelerating the Development of New Therapies for Rare Cardiac Diseases


Excerpt from the Press Release: CHARLESTOWN, Mass. and NAARDEN, The Netherlands, Jan. 11, 2023 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing genetic medicines for neuromuscular and cardiac diseases, and Phlox Therapeutics, a biotech company pioneering a novel approach to gene therapies to alleviate and cure cardiomyopathies, today announced a…

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Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes


Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

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Oncology Pharma Conducting All The Preparations to Take Steps to Forward The Development Process of Nanoemulsion Drug Delivery System


Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / June 29, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) – Oncology Pharma, Inc. (“The Company”) is pleased to be reviewing the financing for taking the steps on moving forward with its development process of. the Nanoemulsuion Drug Delivery System. Many anticancer drugs have been…

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Second Genome Presents New Data at Digestive Disease Week (DDW) 2022 Demonstrating that SG-5-00455, a Potential First-in-Class Precision Therapeutic, Improves Epithelial Barrier Function and Promotes Mucosal Healing in Inflammatory Bowel Disease


Excerpt from the Press Release: Lead development candidate SG-5-00455 shows potential to become first in class PAI-1/2 inhibitor that directly targets mucosal healing in patients with inflammatory bowel disease (IBD) BRISBANE, Calif., May 24, 2022 – Second Genome, a biotechnology company that leverages its proprietary platform to discover and develop precision therapies and biomarkers, presented…

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NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine


Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF Excerpt from the Press Release: SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food…

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Ontario Brain Institute Releases Large Dementia Dataset to Further Accelerate Brain Research, Discovery, and Innovation through Brain-CODE, an Open Science Data Platform


Excerpt from the Press Release: One of the more pressing calls-to-action in the aftermath of the COVID-19 pandemic has been the need to facilitate more accessible, effective, and seamless data sharing across the worldwide research community. The Ontario Brain Institute’s neuroinformatics platform, Brain-CODE, is achieving just that for global brain disorder research – recently launching their third clinical…

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AIM ImmunoTech announces first COVID-19-induced chronic fatigue ‘Long Hauler’ patient dosed with Ampligen


Excerpt from the Article: AIM ImmunoTech Inc (NYSEAMERICAN:AIM) (FRA:HXB2) has announced Wednesday that the active AMP-511 Expanded Access Program (EAP) has dosed its first coronavirus (COVID-19) “Long Hauler” patient with the drug Ampligen (rintatolimod).  The company said the initial dosing marks a significant milestone in its efforts to develop an effective therapeutic for people suffering…

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Albireo Launches Expanded Access Program for Odevixibat for Patients in the U.S., Canada, Australia and Europe


Excerpt from the Press Release: “BOSTON, July 20, 2020 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the launch of an Expanded Access Program (EAP) for investigational lead product candidate odevixibat, a highly potent and selective inhibitor of the ileal bile…

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NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19


Excerpt from the press release: “RADNOR, Pa. and GENEVA, June 24, 2020 (GLOBE NEWSWIRE) — NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute…

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