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  • FDA warns Genetrace for selling HIV Test without Approval
    21 January 2026

    FDA warns Genetrace for selling HIV Test without Approval

    The U.S. Food and Drug Administration (FDA) has issued an official warning letter to Genetrace, a company based in Blaine, Washington, for offering an HIV diagnostic self-collection kit to U.S. customers without proper authorization.

    According to the FDA, the product in question is a dried blood spot (DBS) card self-collection kit that people use at home to collect blood samples and send them to a lab for HIV testing. The agency says this kit qualifies as a medical device because it is meant to help diagnose disease.

  • 21 January 2026
    Lupin Ties Up with Galenicum to Commercialise Injectable Semaglutide Across 23 Global Markets
    Indian pharmaceutical major Lupin Limited has entered into a licensing and supply agreement with Spain-based Galenicum Health, S.L.U. to expand the global availability of injectable Semaglutide, a key GLP-1 receptor agonist used in the treatment of Type 2 diabetes and obesity.
  • 21 January 2026
    Growth Beyond the US Market Lifts India’s Pharma Exports to USD 23.1 Billion
    Indias pharmaceutical exports increased to USD 23.1 billion during April–December 2025–26, up from USD 21.7 billion in the corresponding period of the previous fiscal, reflecting steady demand for Indian medicines in global markets.
  • 17 January 2026
    New Gut Protein Intelectin-2 Shows Promise as Natural Antimicrobial Defender
    Scientists have discovered an important protein in the human gut that can help protect the body from many harmful bacteria. This protein, called intelectin-2, acts as both a defensive barrier-builder and a bacteria-fighting molecule offering new insights into how the body defends itself at mucosal surfaces and pointing to possible future treatments against infections and antibiotic-resistant microbes.
  • 17 January 2026
    Microneedle Technology Poised to Revolutionize Biomacromolecule Delivery

    A new scientific review highlights the rapid evolution of microneedle technology as a versatile and minimally invasive platform for delivering biomacromolecules—large therapeutic molecules used to treat major diseases, including cancer, cardiovascular conditions, metabolic disorders, infections, and autoimmune diseases.

  • 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
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