Latest Headlines

  1. US FDA Accepts Wockhardt's New Drug Application For Breakthrough Antibiotic Zaynich 12/1/2025

    Wockhardt Ltd. today announced that the United States Food and Drug Administration (US FDA) has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.

  2. Eisai Submits New Drug Application For Subcutaneous Formulation Of 'LEQEMBI®' For The Treatment Of Early Alzheimer's Disease In Japan 11/27/2025

    Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has filed a new drug application for “LEQEMBI®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

  3. New Treatment For Acute Myeloid Leukemia 11/25/2025

    Biomedical research that began at the School of Medicine has yielded a much-needed new treatment for patients with the deadliest blood cancer, acute myeloid leukemia.

  4. Drug Discovery Center Integrates AI For Big Impact 11/24/2025

    The UNC Eshelman School of Pharmacy is home to a scientific force driving the future of translational medicine — the Center for Integrative Chemical Biology and Drug Discovery. This center seamlessly blends chemistry, biology and computational science to discover new therapeutic agents and targets.

  5. Tonix Pharmaceuticals Announces FDA IND Clearance For Phase 2 Study Of TNX-102 SL For The Treatment Of Major Depressive Disorder 11/24/2025

    Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults.

  6. HKeyBio Launches The HKEY-AIDMD 3.0--A Next-Generation Platform To Crack The Toughest Challenge In Autoimmune And Allergy Drug Development: Multi-Target Combination Strategy Optimization 11/24/2025

    HKeyBio, a global leading CRO specializing in preclinical and translational research for autoimmune and allergic disease drug development, has officially launched the upgraded HKEY-AIDMD 3.0 platform.

  7. Otsuka Pharmaceutical Submits New Drug Application To U.S. FDA For Centanafadine For The Treatment Of ADHD In Children, Adolescents, And Adults 11/24/2025

    Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults.

  8. BioCorteX Announces Strategic Partnership With CD Biopharma Of China 11/24/2025

    BioCorteX, the UK-based pioneering tech bio company, said Wednesday that it had entered into a strategic collaboration with Chinese biotech company CD Biopharma to accelerate the development of next-generation precision immunotherapy-based drugs that fight solid tumors such as lung and breast cancer.

  9. Avenzo Therapeutics Granted Fast Track Designation For AVZO-103, A Potential Best-In-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, For The Treatment Of Patients With Urothelial Cancer Previously Treated With Enfortumab Vedotin 11/24/2025

    Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (BsADC).

  10. Biodlink And Lepu Biopharma Celebrate Successful Launch Of The World's First EGFR-Targeting ADC Drug, Marking A Major Milestone In Mutual Collaboration In Biologics CMC 11/21/2025

    On November 20, 2025, BioDlink (Stock Code: 1875.HK), a leading biologics CDMO, together with Lepu Biopharma (2157.HK), announced the successful market launch of MEIYOUHENG®(Becotatug Vedotin injection) , the world's first EGFR-targeting antibody-drug conjugate (ADC).