FDA

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) application for VNT-101, a novel direct-acting antiviral against Influenza A virus

09/28/2023

Excerpt from the Press Release: OAKLAND, Calif., Sept. 21, 2023 /PRNewswire/ — Via Nova Therapeutics, Inc., a biotechnology company focused on discovering and developing therapeutics to treat viral infections with significant unmet medical need, today announced the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its…

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Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors

09/01/2023

– CABINET trial will be unblinded and stopped early due to a dramatic improvement in efficacy per a unanimous recommendation by The Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board – – Based on positive results, findings will be discussed with the U.S. Food and Drug Administration – Excerpt from the…

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AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment

08/31/2023

Excerpt from the Press Release: SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug…

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Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials

08/28/2023

Excerpt from the Press Release: BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to…

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Neurophth Announces First Patient Dosed in Phase I/II Clinical Trial of Second Gene Therapy

08/24/2023

Excerpt from the Press Release: WUHAN, China and SAN DIEGO, Aug. 17, 2023 /PRNewswire/ — Neurophth Therapeutics, Inc. (“Neurophth”) announced today that the first patient has been dosed in the international multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation (ND1-LHON). Neurophth is conducting a Phase I/II,…

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Bloom Science Announces Positive Topline Data from a Phase 1 Clinical Trial of BL-001, a Potential First-in-Class Therapeutic Being Developed for Both Dravet Syndrome and ALS

08/23/2023

Excerpt from the Press Release: SAN DIEGO, Aug. 17, 2023 /PRNewswire/ — Bloom Science, Inc., a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis for neurological diseases, today announced positive results from its Phase 1 clinical study in healthy volunteers that demonstrate a favorable safety,…

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

08/16/2023

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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Adamis Pharmaceuticals to Fund ZIMHI® Clinical Study with University of Leiden Opioid Expert

07/31/2023

Excerpt from the Press Release: SAN DIEGO, July 28, 2023 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, today announced the Company has committed to fund an unrestricted research grant to the Leiden University Medical Center (LUMC) Anesthesia and Pain Research Unit. The funding will support the work of Albert Dahan,…

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Ayala Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA Regarding AL102 for the Treatment of Desmoid Tumors

07/19/2023

Company confirms FDA agreement on key elements of the Phase 3 segment of ongoing RINGSIDE study, including dosing regimen of 1.2mg once daily Enrollment in Phase 3 continuing as planned Excerpt from the Press Release: REHOVOT, Israel & MONMOUTH JUNCTION, N.J., July 05, 2023 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology…

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C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

07/17/2023

Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…

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