Current Headlines

  1. Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation For VGT-1849B, A Novel And Selective Candidate For The Treatment Of Polycythemia Vera 8/28/2025

    Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor for the treatment of polycythemia vera (PV).

  2. Foresee Pharmaceuticals Announces FDA Approval Of CAMCEVI ETM For The Treatment Of Advanced Prostate Cancer 8/28/2025

    Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer.

  3. Emory's Center For New Medicines Announces First Cohort Of Therapeutic Projects 8/27/2025

    Founded in 2024, The Center for New Medicines (CNM) aims to harness the plethora of discoveries from across the Emory ecosystem to accelerate them into the early stages of drug development.

  4. Grace Therapeutics Announces U.S. Food And Drug Administration Acceptance For Review Of New Drug Application For GTx-104 8/27/2025

    Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced that on August 22, 2025 the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for GTx-104 for formal review.

  5. SwRI Develops An ion-assisted Chromatography Process To Accelerate Drug Development 8/27/2025

    Southwest Research Institute scientists developed a new purification technique to improve chromatography results without expensive purification materials or equipment. Chromatography is an essential part of drug discovery, development and quality control, allowing scientists to isolate and synthesize active pharmaceutical ingredients (APIs) that meet U.S. Food & Drug Administration purity standards.

  6. Nanyang Biologics Collaborates With Equinix And HPE To Make AI Driven Drug Discovery Platform And Build World's Largest Natural Drug Compound Library In Singapore 8/26/2025

    In a milestone step towards enhancing Singapore’s leadership in AI-driven biomedical innovation, homegrown Nanyang Biologics Pte Ltd (NYB), an award-winning AI-driven biotech firm spun out from Nanyang Technological University (NTU) over the past seven years, is working with Equinix and HPE to offer Vecura, an as-a-Service proprietary AI-driven platform for drug discovery to advance development from natural sources.

  7. Dr. Reddy's Launches Linaclotide (Colozo) A Novel Drug For Chronic Constipation Management In Adults, In India 8/26/2025

    Dr. Reddy’s Laboratories Ltd., announced the launch of Linaclotide, a first-in-class guanylate cyclase-C (GC-C) agonist for adults suffering from chronic constipation in India. Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo, available in 72 mcg and 145 mcg strengths.

  8. iXCells Biotechnologies Selected To Perform The First Pilot In Patient-Led ALS Precision Medicine Effort 8/26/2025

    Mosaic Neuroscience and iXCells Biotechnologies USA, Inc. (“iXCells”) today announced a groundbreaking pilot project aimed at making it easier to develop precision drugs for ALS, a notoriously complex and deadly disease.

  9. Creative Bioarray Launches High-Throughput ADME Screening Service To Accelerate Drug Development 8/25/2025

    Creative Bioarray, one of the world’s leading biotechnology products and services providers, striving to exceed the expectations by consistently delivering results with exceptional quality. Creative Bioarray is dedicated to accelerating the research in clinical trials, biomarker development and testing, or drug discovery support. Recently, Creative Bioarray announced the release of its high-throughput ADME screening services, helping clients can quickly identify lead candidates with favorable ADME profiles, leading to faster advancements in biologics-based therapies.

  10. Coya Therapeutics Announces FDA Acceptance Of Investigational New Drug (IND) Application For COYA 302 For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) 8/25/2025

    Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302.