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  • Zydus Enters U.S. BioCDMO Market With Launch of Zylidac Bio LLC After Closing Agenus Facilities Deal
    16 January 2026

    Zydus Enters U.S. BioCDMO Market With Launch of Zylidac Bio LLC After Closing Agenus Facilities Deal

    Zydus Lifesciences Limited has completed the acquisition of biologics manufacturing facilities from U.S.-based Agenus Inc., marking a major step in its global biologics and contract development and manufacturing (CDMO) strategy. Following regulatory clearances, including approval from the Committee on Foreign Investment in the United States (CFIUS), the acquired assets will operate under a newly formed U.S. subsidiary, Zylidac Bio LLC.

  • 16 January 2026
    Sentynl Therapeutics Secures FDA approval for ZYCUBO® to Treat Menkes Disease

    Sentynl Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZYCUBO® (copper histidinate) for the treatment of patients with Menkes disease, a rare, inherited disorder that affects copper absorption and distribution in the body.

  • 16 January 2026
    Dr. Reddy’s Launches First-to-Market OTC Olopatadine 0.7% Eye Drops in the U.S.

    Dr. Reddy’s Laboratories Ltd. announced the first-to-market launch of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) in the United States, following approval from the U.S. Food and Drug Administration (USFDA). The product is the generic equivalent of Extra-Strength Pataday® (of Novartis AG) Once-Daily Relief, a leading over-the-counter antihistamine eye drop.

  • 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.
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