FDA

Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes

10/12/2023

BMF-219 is a novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 1 diabetes Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to…

Read More

Aligos Therapeutics Announces IND Clearance for NASH lead, ALG-055009

10/02/2023

– Phase 2a NASH protocol on track to be submitted to the IND in Q4 2023, enrollment expected to begin in Q1 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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,…

Read More

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,…

Read More

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…

Read More

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,…

Read More