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  • FDA issues Warning Letter to Indian Clinical Investigator over Bioequivalence Study Violations
    15 January 2026

    FDA issues Warning Letter to Indian Clinical Investigator over Bioequivalence Study Violations

    The U.S. Food and Drug Administration (FDA) has issued a formal warning letter to a clinical investigator at Senthil Specialty Hospital in Pondicherry, India, citing significant violations of federal regulations during a clinical bioequivalence study
  • 15 January 2026
    FDA and EU unveil unified principles to guide AI’s role in Drug Discovery and Development
    U.S. Food and Drug Administration in collaboration with the European Medicines Agency EMA, has released a set of Guiding Principles for Good AI Practice in Drug Development
  • 12 January 2026
    CuraTeQ Biologics gets Health Canada NOC for Pegylated Filgrastim Biosimilar Dyrupeg

    CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has received a Notice of Compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for Dyrupeg™, its pegylated filgrastim biosimilar.

  • 12 January 2026
    Biocon Pharma Secures USFDA Approval for Everolimus Tablets for Oral Suspension

    Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension. The approval covers 2 mg, 3 mg and 5 mg strengths.

  • 7 January 2026
    Europe Greenlights Easier-to-Use Shingrix Vaccine Format for Shingles Prevention

    GSK has announced a significant regulatory milestone in adult immunisation with the European Commission’s approval of a new prefilled syringe presentation for its widely used shingles vaccine, Shingrix. This updated format is designed to simplify the administration process for healthcare professionals by removing the need to mix components before injection — a step required in the current two-vial version. The approval paves the way for rollout across EU countries throughout 2026.

  • 7 January 2026
    Dual-Drug Breakthrough: A new pathway to treat Liver Fibrosis
    Researchers have identified a promising new treatment strategy for liver fibrosis, a chronic condition that can lead to cirrhosis and liver cancer, by combining two well-known drugs. Preliminary findings suggest that using silybin together with carvedilol produces a powerful synergistic effect significantly stronger than either drug alone, against the cellular processes that drive scar tissue formation in the liver.
  • 7 January 2026
    Infant gut molecules offer clues to type 1 Diabetes risk
    In a groundbreaking study, scientists have uncovered a new class of gut-derived molecules in infancy that could reshape how researchers understand the development of type 1 diabetes. The international research team, led by experts at the University of Turku and Örebro University, investigated stool samples from more than 300 children between the ages of 3 and 36 months, all of whom had a genetic predisposition for type 1 diabetes.
  • 6 January 2026
    FDA nods first pediatric therapy for rare blood disorder aTTP

    The U.S. Food and Drug Administration has approved Cablivi (caplacizumab-yhdp) for pediatric patients 12 years and older suffering from acquired thrombotic thrombocytopenic purpura (aTTP), marking the first time a treatment has been authorized for this extremely rare condition in children.

  • 6 January 2026
    ScinoPharm gets U.S. FDA approval for Multiple Sclerosis treatment
    ScinoPharm Taiwan has clinched a landmark regulatory victory by securing U.S. Food and Drug Administration (FDA) approval for its Glatiramer Acetate Injection, a treatment used to manage multiple sclerosis (MS), the company announced
  • 5 January 2026
    China’s Supreme People’s Court Upholds Semaglutide Patent in Major Win for Novo Nordisk

    Novo Nordisk has received a significant legal victory in China’s Supreme People’s Court, which affirmed the validity of the company’s semaglutide compound patent, strengthening intellectual property protections for one of its most important medicines.

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