Latest Headlines

  1. Cogent Biosciences To Initiate New Drug Application (NDA) Submission For Bezuclastinib Under Real-Time Oncology Review (RTOR) 1/20/2026

    Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program.

  2. Celcuity Announces FDA Acceptance Of New Drug Application For Gedatolisib In HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer 1/20/2026

    Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”).

  3. SandboxAQ Supercharges OpenFold3 With AQAffinity: High-Speed, Structure-Free Drug Potency Prediction 1/20/2026

    SandboxAQ today launched AQAffinity, a powerful new AI model designed to unblock one of the most persistent bottlenecks in drug discovery: the need for experimentally determined structures.

  4. Abcam Joins The Innovative Health Initiative LIGAND-AI Project To Advance Artificial Intelligence (AI)-Driven Drug Discovery Through Open Science 1/20/2026

    Abcam and the other 17 members of the partnership today launched the IHI project, LIGAND-AI, to advance AI-driven drug discovery through open science.

  5. Lantern Pharma's LP-284 Receives FDA Orphan Drug Designation For Soft Tissue Sarcomas 1/20/2026

    Lantern Pharma Inc., a clinical-stage biopharmaceutical company using artificial intelligence to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LP-284 for the treatment of soft tissue sarcomas.

  6. Using AI To Accelerate Drug Development 1/19/2026

    Drug development is an arduous process that costs billions of dollars and can last for years or even decades.

  7. Organon Announces US Food And Drug Administration Approval Of Supplemental New Drug Application Extending Duration Of Use Of NEXPLANON (etonogestrel implant) 68 mg Radiopaque 1/16/2026

    Organon, a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy.

  8. Emergent BioSolutions Receives U.S. FDA Approval On Supplemental New Drug Application For NARCAN® Nasal Spray To Be Packaged In A New Carrying Case, Making Life-Saving Naloxone More Accessible For Everyday Preparedness 1/14/2026

    Today, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for over-the-counter (OTC) NARCAN® Nasal Spray to be packaged in a new carrying case, which includes two blister packs, each enclosed with Quick Start Guide.

  9. Illumina Introduces Billion Cell Atlas To accelerate AI And Drug Discovery 1/13/2026

    Illumina, Inc. (NASDAQ: ILMN) today introduced the world's largest genome-wide genetic perturbation dataset, being built to accelerate drug discovery through AI across the pharmaceutical ecosystem.

  10. Tahoe Therapeutics And Alloy Therapeutics To Form Joint Venture And Develop First-In-Class Antibody-Drug Conjugates For Hard-To-Treat Cancers 1/13/2026

    Tahoe Therapeutics and Alloy Therapeutics announced today that they are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers.