Business Wire

  1. Latus Bio Announces IND Clearance Of LTS-101 For CLN2 Disease And Receipt Of Fast Track, Orphan Drug, And Rare Pediatric Disease Designations 12/2/2025

    Latus Bio, Inc. (Latus), a biotechnology company pioneering advances in adeno-associated virus (AAV) gene therapy, today announces clearance by the U.S. Food and Drug Administration (FDA) of the Company’s Investigational New Drug (IND) application for LTS-101 - a gene therapy candidate that’s intended to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease.

  2. 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.

  3. 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.

  4. 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).

  5. Emulate Launches Brain-Chip R1 To Advance Neurological Drug Development, In Partnership With FUJIFILM Cellular Dynamics 11/18/2025

    Emulate, Inc., the leading provider of next-generation Organ-on-a-Chip technology, in partnership with FUJIFILM Cellular Dynamics, Inc., a pioneering global developer and manufacturer of human induced pluripotent stem cells (iPSCs), today announced the launch of the Emulate Brain-Chip R1.

  6. Terray Announces EMMI, An AI-Native Drug Discovery Platform For de Novo Small Molecule Drug Discovery 11/17/2025

    Terray Therapeutics, an AI-native, chemistry-first, biotech today announced its AI and experimental platform, EMMI, and the introduction of advanced Select models that choose the most impactful molecules to make and test in every cycle of drug discovery.

  7. BenchSci And Mila Partner To Advance AI For Biological Inference And Accelerate Drug Discovery 11/12/2025

    BenchSci, a leading provider of AI software for biopharma research and development, and Mila - Quebec Artificial Intelligence Institute, one of the world’s premier AI research centers, today announced a multi-year partnership to advance the use of artificial intelligence for biological inference.

  8. BostonGene And Kyoto University Partner To Accelerate Precision Drug Development 11/12/2025

    BostonGene, developer of the leading AI foundation model for cancer and the immune system, and Kyoto University, a research institution known for its groundbreaking advancements in medicine and science announced today a research collaboration to develop advanced biological signatures to enhance targeted treatment strategies for patients with esophageal squamous cell carcinoma (ESCC).

  9. Avenzo Therapeutics Granted Fast Track Designation For AVZO-1418, A Potential Best-In-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate, For The Treatment Of Patients With EGFR-Mutated TKI-Pretreated NSCLC 11/10/2025

    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-1418 (DB-1418), a potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate (BsADC).

  10. Tenpoint Therapeutics Ltd. Announces Submission Of A New Drug Application For BRIMOCHOL PF For The Treatment Of Presbyopia To The MFDS In South Korea 11/5/2025

    Tenpoint Therapeutics, Ltd., a global, commercial-ready biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announced that its partner, Zhaoke Ophthalmology Ltd. (“Zhaoke Ophthalmology”), a leading ophthalmic pharmaceutical company, has supported its South Korean partner, Kwangdong Pharmaceutical Co., Ltd. (“KDP”), in submitting a New Drug Application (NDA) for BRIMOCHOL PF to the Ministry of Food and Drug Safety (MFDS) in South Korea. KDP will be responsible for the manufacturing and distribution of BRIMOCHOL PF in South Korea.