Latest Headlines

1. Axsome Therapeutics Announces FDA Acceptance And Priority Review Of Supplemental New Drug Application For AXS-05 For The Treatment Of Alzheimer's Disease Agitation 12/31/2025

   Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer’s disease agitation, and has granted the application Priority Review designation.

2. Cogent Biosciences Announces Submission Of New Drug Application For Bezuclastinib In Nonadvanced Systemic Mastocytosis 12/30/2025

   Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM).

3. New Computational Method 'Fast-Tracks' Drug Discovery 12/30/2025

   PathGennie, a novel computational framework developed by scientists can significantly accelerate the simulation of rare molecular events.

4. Sinopia Biosciences Awarded NIGMS Grant To Advance LEADS Platform For Data-Driven Drug Discovery 12/30/2025

   Sinopia Biosciences, Inc., a biotechnology company advancing novel therapeutics identified using its proprietary LEADS drug discovery platform, announced today it has been awarded a research grant from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH), to further advance its data-driven drug discovery capabilities.

5. OHSU Researchers Find Breast Cancer Drug Boosts Leukemia Treatment 12/29/2025

   A research team at Oregon Health & Science University has discovered a promising new drug combination that may help people with acute myeloid leukemia overcome resistance to one of the most common frontline therapies.

6. Unicycive Therapeutics Announces Resubmission Of New Drug Application (NDA) For Oxylanthanum Carbonate (OLC) 12/29/2025

   Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

7. Harbour Biomed Enters Into Long-Term Strategic Collaboration With Lannacheng To Advance Next-Generation Radionuclide Drug Conjugates 12/28/2025

   Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced that it has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology Co., Ltd.

8. CARsgen Submits Dual IND Applications For Allogeneic BCMA CAR-T Product CT0596 12/28/2025

   CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596.

9. Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission For Phase 2 Clinical Study In Weight Management, Expanding Development Combined With GLP-1RA-Based Weight-Loss Therapies 12/24/2025

   Caliway Biopharmaceuticals (TWSE: 6919) today announced that it has completed the submission of an Investigational New Drug (IND) application to the U.S. FDA for a Phase 2 clinical study of its world's first large-area localized fat reduction drug candidate, CBL-514, for the weight management indication.

10. Zai Lab Announces Approval Of COBENFY (xanomeline And trospium chloride) In China, A First-In-Class Therapy For Schizophrenia 12/23/2025

    Zai Lab Limited today announced that China’s National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for COBENFY (xanomeline and trospium chloride) for the treatment of schizophrenia in adults.