Latest Headlines

  1. Teva Pharmaceuticals Submits New Drug Application To FDA For Olanzapine Extended-Release Injectable Suspension (TEV-'749) For The Once-Monthly Treatment Of Schizophrenia In Adults 12/9/2025

    Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.

  2. Bora Pharmaceuticals And Corealis Pharma Forge Strategic Alliance To Deliver Seamless, End-To-End Oral Solid Dose Development 12/9/2025

    Bora Pharmaceuticals Co., Ltd. ("Bora", TWSE: 6472), a global leader in pharmaceutical manufacturing, and Corealis Pharma Inc., a leading early-phase Contract Development Manufacturing Organization (CDMO), have entered into a strategic alliance to provide end-to-end services for oral solid dose (OSD) development and manufacturing.

  3. Ocular Therapeutix™ Announces Plans To Accelerate NDA Submission Timeline For AXPAXLI™ In Wet AMD 12/8/2025

    Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026.

  4. Ouro Medicines Receives U.S. FDA Orphan Drug Designation For Gamgertamig (OM336) For Immune Thrombocytopenia 12/8/2025

    Ouro Medicines, a biotechnology company developing immune reset therapeutics for people living with chronic, immune-mediated diseases, today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody candidate, has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for development in the treatment of immune thrombocytopenia (ITP).

  5. Agora Open Science Trust Announces Nomination Of M4K2009 As Lead Development Candidate For Pediatric Brain Cancer Therapy 12/8/2025

    Agora Open Science Trust today announced the nomination of M4K2009 as the lead development candidate for its M4K Pharma program, which applies open science to drive the development of an affordable treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare and devastating pediatric brain cancer.

  6. AI-For-Science Startup ChemLex Raises USD 45M, Launching Self-Driving Lab For Drug Discovery In Singapore 12/7/2025

    ChemLex, a next-generation AI-for-science company, today announced the establishment of its global headquarters and self-driving laboratory in Singapore, alongside the close of a USD 45 million funding round led by Granite Asia.

  7. Advanced Brain Imaging Reveals Promise Of New Drug For Parkinson's Disease 12/4/2025

    University of Queensland researchers have developed a promising new anti-inflammatory drug and, for the first time, used advanced imaging to watch its effects unfold inside the living brain, a breakthrough that could accelerate treatments for Parkinson’s disease.

  8. Terray Therapeutics Achieves AI-Enabled Drug Discovery Milestone In Collaboration With Bristol Myers Squibb 12/3/2025

    Terray Therapeutics (www.terraytx.ai), a chemistry-first, AI-native biotech company, today announced the achievement of a discovery milestone in the company’s multi-target collaboration with Bristol Myers Squibb.

  9. Galux And Celltrion Enter Strategic Partnership To Co-Develop Next-Generation Multispecific Antibodies For Autoimmune Diseases 12/2/2025

    Galux announced a joint collaboration with Celltrion, a leading biopharmaceutical company based in Incheon, to co-develop next-generation multispecific antibodies for autoimmune diseases.

  10. U.S. FDA Grants Birchbiomed Orphan Drug Designation For FS2 In The Treatment Of Idiopathic Pulmonary Fibrosis 12/2/2025

    BirchBioMed Inc., a leading clinical stage biopharmaceutical company, expert in the development of products for scarring and other fibrosis-related disorders and autoimmune therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis (IPF).