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  • FDA Opens New Era in Pediatric Diabetes Care with First OTC Continuous Glucose Monitor

    In a landmark step for diabetes management, the U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) continuous glucose monitor (CGM) for use in children. The decision expands the indication of Dexcom’s Stelo Glucose Biosensor System, making it the first prescription-free CGM available for pediatric patients.

  • J&J’s IMAAVY Shows Rapid, Durable Benefit in Rare Blood Disorder With No Approved Treatments
    J&J’s IMAAVY Shows Rapid, Durable Benefit in Rare Blood Disorder With No Approved Treatments

    Johnson & Johnson has announced encouraging results from its pivotal Phase 2/3 ENERGY study evaluating IMAAVY (nipocalimab-aahu) in patients with warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune blood disorder that currently has no FDA-approved therapies. The findings suggest that the investigational treatment could offer a much-needed targeted option for patients struggling with chronic anemia and severe fatigue.

  • Novo Nordisk Confirms Cybersecurity Incident Involving Clinical Trial Data
    Novo Nordisk Confirms Cybersecurity Incident Involving Clinical Trial Data
    Danish pharmaceutical giant Novo Nordisk has disclosed an IT security incident that resulted in unauthorized access to a limited number of its internal systems, including data related to some clinical trial participants. The company stated that certain non-public information was copied externally without authorization and that an investigation is currently underway.
  • Japanese Scientists Uncover Immune Cell Feedback Loop Driving Sjögren’s Disease
    Japanese Scientists Uncover Immune Cell Feedback Loop Driving Sjögren’s Disease

    Researchers from Keio University School of Medicine in Japan have identified a previously unknown immune mechanism that may be responsible for sustaining the chronic autoimmune response seen in Sjögren’s disease. The discovery sheds new light on how the disease progresses and could open the door to targeted treatments that avoid the broad immune suppression associated with current therapies.

  • India Targets USD 50 Billion Pharmaceutical Exports by 2030 Through Quality, Innovation and Global Collaboration
    India Targets USD 50 Billion Pharmaceutical Exports by 2030 Through Quality, Innovation and Global Collaboration

    India is aiming to achieve pharmaceutical exports worth USD 50 billion by 2030, driven by a strong focus on quality manufacturing, innovation, regulatory excellence, and international collaboration. The vision was highlighted during discussions involving global drug regulators, industry leaders, and policymakers, underscoring India's ambition to strengthen its position as a leading supplier of medicines to the world.

  • Weekly HIV Pill Moves Closer to Reality as Gilead and Merck Report Positive Phase 3 Results
    Weekly HIV Pill Moves Closer to Reality as Gilead and Merck Report Positive Phase 3 Results

    In a major advancement for HIV treatment, Gilead Sciences and Merck have announced positive topline results from two pivotal Phase 3 clinical trials evaluating an investigational once-weekly oral HIV therapy that combines islatravir and lenacapavir. The promising findings bring the healthcare industry one step closer to introducing what could become the world's first long-acting oral HIV treatment taken just once a week.

  • Biomarker-Guided Immunosuppression Found Safe in Kidney Transplant Patients, Major European Study Shows
    Biomarker-Guided Immunosuppression Found Safe in Kidney Transplant Patients, Major European Study Shows

    A groundbreaking European clinical trial has shown that using a common, harmless virus as a biomarker to guide immunosuppressive treatment after kidney transplantation is both safe and effective, paving the way for more personalized transplant care.

  • First-Ever Gene Therapy Delivered Directly to Infant’s Brain Offers Hope for Rare Genetic Epilepsy
    First-Ever Gene Therapy Delivered Directly to Infant’s Brain Offers Hope for Rare Genetic Epilepsy

    In a groundbreaking advancement for precision medicine, doctors in Israel have successfully administered the world's first gene replacement therapy directly into the brain of an infant suffering from a rare and devastating genetic epilepsy disorder. The experimental treatment aims to restore the function of the defective WWOX gene, offering new hope to children affected by this life-threatening condition.

  • Takeda Faces Financial Hit as Amitiza Antitrust Case Impacts Earnings
    Takeda Faces Financial Hit as Amitiza Antitrust Case Impacts Earnings
    Takeda Pharmaceutical has revised its financial results for fiscal year 2025 following a significant legal development in the United States involving its constipation drug, Amitiza, lubiprostone
  • Bayer’s Finerenone Shows Strong Protection Against Kidney and Heart Complications in CKD Patients
    Bayer’s Finerenone Shows Strong Protection Against Kidney and Heart Complications in CKD Patients

    Bayer has announced promising new findings showing that finerenone, its non-steroidal mineralocorticoid receptor antagonist, significantly lowers the risk of chronic kidney disease (CKD) progression and major cardiovascular complications across a broad range of patients living with CKD. The latest results were presented during the 63rd European Renal Association (ERA) Congress.

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