Latest Headlines

  1. ArkBio Announces China IND Approval For Its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 For Influenza Prophylaxis 8/13/2026

    Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the Investigational New Drug (IND) application for AK0406 injection, the company's first long-acting antiviral drug‑Fc conjugate (AFC) candidate for influenza prophylaxis, has been approved by the National Medical Products Administration (NMPA) of China, making AK0406 the first influenza AFC drug to enter clinical development in China.

  2. Belite Bio Announces U.S. Food And Drug Administration Acceptance And Priority Review Of New Drug Application For Tinlarebant For The Treatment Of Stargardt Disease Type 1 8/11/2026

    Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1).

  3. EIT Pharma Announces FDA Acceptance Of New Drug Application For Lonafarnib For Treatment Of Chronic Hepatitis D 8/11/2026

    EIT Pharma, Inc. ("EIT Pharma" or the "Company"), a biotechnology company focused on developing therapies for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for lonafarnib for the treatment of chronic hepatitis D.

  4. New Drug Application For LAE002 (afuresertib) Accepted By China's National Medical Products Administration 8/11/2026

    Laekna (2105.HK) announced today that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor).

  5. Graviton BioScience Announces Clearance Of Investigational New Drug (IND) For GV101 For The Treatment Of Friedreich's Ataxia 8/11/2026

    Graviton BioScience Corporation, a privately held, clinical-stage biotechnology company developing a diverse pipeline of therapeutics, including selective ROCK2 inhibitors for metabolic, inflammatory, fibrotic, and central nervous system disorders, announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a novel capsule formulation of GV101, a proprietary oral ROCK2 inhibitor being developed for Friedreich's ataxia (FA).

  6. Bruker Announces Majority Investment In MIMETAS To Advance Human Physiology-Relevant Drug Discovery And Development 8/10/2026

    Bruker Corporation today announced a majority investment in MIMETAS B.V., a developer of organ-on-a-chip platforms and advanced human tissue and disease models for drug discovery and development.

  7. Lupin Announces The Approval Of Sodium Zirconium Cyclosilicate For Oral Suspension In The United States 8/10/2026

    Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet.

  8. Senhwa's CX-5461 Reaches Immuno-Oncology Milestone As Its First Multicenter Combination Trial With PD-1 Inhibitor Receives TFDA Clearance 8/6/2026

    Senhwa Biosciences, Inc. (TPEx: 6492) today announced that the Taiwan Food and Drug Administration (TFDA) has cleared the Company's multicenter Phase 1b/2a clinical trial evaluating its investigational drug pidnarulex (CX-5461) in combination with a marketed PD-1 immune checkpoint inhibitor.

  9. Ono Pharma Enters Into A Drug Discovery Partnership With Mediar Therapeutics To Create Novel Antibody Therapeutics For Fibro-Inflammatory Diseases 8/6/2026

    Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) announced today that it has entered into a drug discovery partnership and option agreement with Mediar Therapeutics, Inc.

  10. Greenstone Biosciences Receives NIH R61 Grant To Advance Cardiac Fibrosis Therapeutics For Duchenne Muscular Dystrophy 8/6/2026

    Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, today announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH).