Latest Headlines

  1. GenBio AI Builds First World Model Of The Human Cell 8/18/2026

    GenBio AI ('GenBio') is an AI for Science company co-founded by Nobel Laureate David Baker, leading AI scientist Eric Xing, and other prominent life science and artificial intelligence researchers from Stanford, Carnegie Mellon University, Mohamed Bin Zayed University of Artificial Intelligence, Harvard, Weizmann Institute, and other research institutions.

  2. Amygdala Neurosciences Announces FDA Clearance Of Investigational New Drug (IND) Application For ANS-858 8/18/2026

    Amygdala Neurosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ANS-858, enabling the Company to advance ANS-858 into clinical development.

  3. Tagomics Introduces LiquiPath, A First-In-Class cfDNA-Based Blood Test For Multi-Organ Drug Safety Monitoring 8/17/2026

    Tagomics Ltd., a pioneering precision medicine company, today announced the launch of LiquiPathTM, a cross-species, multi-organ “liquid pathology” platform, for non-invasive drug safety monitoring.

  4. OncoC4 Announces First Patient Dosing In Phase 1 Clinical Trial Of ONC-783 For The Treatment Of Advanced Solid Tumors 8/17/2026

    OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company's investigational T-cell engager developed based on the proprietary neoCD24 platform.

  5. TCS launches Agentic AI Platform To Transform Drug Development 8/17/2026

    Tata Consultancy Services (TCS), a global leader in IT services, consulting, and business solutions, has launched TCS ADD AgentHub, a role-based, enterprise-ready, and trusted AI platform that enables the use of agentic AI in drug development at scale.

  6. Phanes Therapeutics Receives FDA Fast Track Designation For Spevatamig In Advanced And Metastatic Biliary Tract Carcinoma 8/14/2026

    Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology, announced that the U.S. Federal and Drug Administration (FDA) has granted Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma.

  7. 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.

  8. 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).

  9. 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.

  10. 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).