Latest Headlines

  1. Sapience Therapeutics Receives FDA Orphan Drug Designation For ST316, A First-In-Class β-catenin Antagonist, For The Treatment Of Familial Adenomatous Polyposis (FAP) 12/19/2024

    Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ST316 for the treatment of familial adenomatous polyposis (FAP).

  2. New Molecule-Creation Method A 'Powerful Tool' To Accelerate Drug Synthesis And Discovery 12/19/2024

    A team of chemists from Scripps Research and Rice University has unveiled a novel method to simplify the synthesis of piperidines, a key structural component in many pharmaceuticals. The study, published in Science, combines biocatalytic carbon-hydrogen oxidation and radical cross-coupling, offering a streamlined and cost-effective approach to create complex, three-dimensional molecules.

  3. NGM Bio And KdT Ventures Enter Into Worldwide License Agreement For NGM313, A Phase 2-Ready FGFR1c/Β-Klotho Agonist Drug Candidate 12/19/2024

    NGM Biopharmaceuticals, Inc. (NGM Bio) and KdT Ventures today announced the signing of a worldwide license agreement for NGM313, a Phase 2-ready FGFR1c/β-Klotho receptor complex agonistic antibody.

  4. First Successful Clinical Trial Of VU319 Brings Alzheimer's Treatment One Step Closer 12/19/2024

    Researchers at the Warren Center for Neuroscience Drug Discovery, a clinical stage biotech within the Vanderbilt University School of Medicine Basic Sciences, have detailed the successful drug discovery of a Phase I Single Ascending Dose clinical trial of VU319, a drug for memory loss in people with Alzheimer’s disease and schizophrenia.

  5. Tonix Pharmaceuticals Announces FDA Acceptance Of The New Drug Application (NDA) For TNX-102 SL For Fibromyalgia 12/19/2024

    Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia. 

  6. ViGeneron Announces FDA Clearance Of IND For Novel mRNA Trans-Splicing Gene Therapy VG801 To Treat Stargardt Disease And Other ABCA4-Linked Retinal Dystrophies 12/18/2024

    ViGeneron GmbH, a next-generation clinical-stage gene therapy company, today announced that the United States Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase I/II study of VG801, a potentially transformative gene therapy to treat Stargardt disease and other retinal dystrophies associated with mutations in the ABCA4 gene.

  7. Medera's Novoheart And Curi Bio Partner To Transform Human-Based Cardiac Drug Screening 12/18/2024

    Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, today announced that its wholly owned preclinical subsidiary for disease modelling and drug discovery, Novoheart, has entered into a transformative partnership with Curi Bio Inc., a leader in preclinical screening technologies.

  8. Merck Announces FDA Acceptance Of Biologics License Application For Clesrovimab, An Investigational Long-Acting Monoclonal Antibody Designed To Protect Infants From RSV Disease During Their First RSV Season 12/17/2024

    Merck known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.

  9. Gilead And Terray Therapeutics Announce Multi-Target Research Collaboration To Discover And Develop Novel Small Molecule Therapies 12/17/2024

    Gilead Sciences, Inc.and Terray Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets.

  10. Images Of Crucial Cell Receptors Show Promising New Drug Targets 12/17/2024

    Almost 35% of drugs approved by the Food and Drug Administration work by targeting G protein-coupled receptors (GPCRs), proteins embedded in cell membranes that allow cells to communicate with each other.