Latest Headlines

  1. GATC Health Joins Critical Path Institute's New Approach Methodologies Developer Coalition To Advance AI-Enabled Regulatory Science 9/14/2026

    GATC Health Corp (“GATC”), a tech-bio company applying artificial intelligence and multiomics to accelerate drug discovery and development, today announced that it has joined the Critical Path Institute’s® (C-Path) New Approach Methodologies Developer Coalition (NAMs-DC), a precompetitive coalition working to advance the adoption, validation and qualification of new approach methodologies (NAMs) for drug discovery and development.

  2. FDA Approves Telix's Brain Cancer Imaging Drug Pixclara 9/14/2026

    Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer).

  3. Sapience Therapeutics Announces FDA Acceptance Of Investigational New Drug Application For ST316 In Familial Adenomatous Polyposis (FAP) 9/14/2026

    Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated with the development of hundreds to thousands of precancerous colorectal polyps and a significantly increased risk of colorectal cancer.

  4. Accro Bioscience Announces Inclusion Of AC-101 Tablets In The NMPA CDE's 'Caring Plan-Extension' Pilot Program For Rare Disease Drug Development 9/13/2026

    On September 14, 2026 (China Standard Time, UTC+8), Accro Bioscience announced that AC-101 tablets have been included in the Rare Diseases Innovative Drug Development Encouragement Pilot Program (the "Caring Plan-Extension", known in Chinese as "Care Program - Extension" of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), with Blau syndrome as the proposed indication.

  5. EPIK Biosciences Advances Combination Medicines Across Ketamine-Based And DXM-Based Programs, Supported By 34 Provisional Drug Patent Applications 9/10/2026

    EPIK Biosciences (“EPIK” or the “Company”) today announced continued progress as a drug development company advancing proprietary synergistic combination medicines for mental health disorders, severe and chronic pain, and substance use disorders. Brandon Romanek, Founder and CEO of EPIK, is the inventor of the Company’s portfolio of medicines.

  6. Lonza Further Strengthens US Manufacturing Presence With Addition Of A Commercial Spray-Drying Facility In Bend, Oregon 9/10/2026

    Lonza, the world’s leading contract development and manufacturing organization (CDMO), announced today plans to further strengthen its significant US presence by constructing a large-scale commercial spray-drying facility in Bend, Oregon. The investment will establish Lonza as the leading CDMO provider of commercial-scale spray-drying PSD-4 capacity in the US.

  7. Creative Biolabs Expands Integrated AI-Driven Chemical Synthesis Platforms To Accelerate Next-Generation Drug Discovery 9/9/2026

    The platform integrates AI-based molecular design, synthetic feasibility assessment, automated chemical synthesis, and experimental validation within a unified DMTA (design-make-test-analyze) workflow. By operating under this cohesive capability framework, the company delivers tailored discovery pipelines spanning small molecules, antibody-drug conjugates (ADCs), and targeted protein degraders (PROTACs).

  8. Emulate Enters Final Stage Of FDA ISTAND Program For Human Liver-Chip With Submission Of Qualification Package Covering Both Zoë And AVA Organ-Chip Platforms 9/9/2026

    Emulate, Inc., the leading provider of next-generation Organ-on-a-Chip technology, today announced it has submitted its FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) full qualification package (FQP) for its Human Liver-Chip, advancing the company's efforts to establish Organ-on-a-Chip technology as a qualified Drug Development Tool (DDT) for drug-induced liver injury (DILI) assessment.

  9. Satellos Announces Forazapadin As Assigned International Nonproprietary Name For Lead Drug Candidate, SAT-3247 9/9/2026

    Satellos Bioscience (Nasdaq: MSLE, TSX: MSCL), a clinical-stage drug development company developing life-improving medicines to treat degenerative muscle diseases, today announced the assignment of the International Nonproprietary Name (INN) “forazapadin” for the Company's orally administered, small molecule drug candidate designed to restore muscle regeneration that was previously known as SAT-3247.

  10. Insilico Medicine Doses First Patient In GENESIS-IPF-3, The World's First Phase III Trial Of A Generative AI-Driven Innovative Drug 9/9/2026

    Insilico Medicine ("Insilico," HKEX: 3696), a clinical-stage biotechnology company powered by generative AI, today announced that it has dosed the first patient with Rentosertib (known as ISM001-055 / INS018_055) in GENESIS-IPF-3, a Phase III clinical trial (NCT07687459, CTR20262475) at Peking Union Medical College Hospital, while Shanghai Pulmonary Hospital has also enrolled its first patient on the same day.