• FDA Flags Medtronic Pulmonary Valve Delivery System Recall as Class I Over Risk of Catheter Tip Detachment
    14 July 2026

    FDA Flags Medtronic Pulmonary Valve Delivery System Recall as Class I Over Risk of Catheter Tip Detachment

    The U.S. Food and Drug Administration (FDA) has announced a Class I recall, its most serious recall category, for certain Medtronic Harmony™ Delivery Catheter Systems (DCS) used to implant transcatheter pulmonary valves. The recall follows concerns that a manufacturing defect could cause the catheter's distal tip to detach during implantation, potentially leading to serious complications, including emergency surgery or death.

  • FDA Approves First At-Home Starting Dose for Alzheimer's Therapy, Expanding Access to Early Treatment
    14 July 2026
    FDA Approves First At-Home Starting Dose for Alzheimer's Therapy, Expanding Access to Early Treatment

    The U.S. Food and Drug Administration (FDA) has approved the first at-home starting dose for an Alzheimer's disease treatment, marking a significant advancement in the management of early Alzheimer's disease. The approval allows eligible patients to begin therapy using a subcutaneous (under-the-skin) injection at home, either by self-administration or with the assistance of a caregiver, reducing the need for hospital or infusion-center visits.

  • Quality Control and Quality Assurance Jobs at USV Private Limited
    11 July 2026
    Quality Control and Quality Assurance Jobs at USV Private Limited
    B.Pharm / M.Pharm / M.Sc . Expertise in analysis on HPLC, GC, Assay, Dissolution. Method Validation Protocol creation and execution, Expertise in handling HPLC, ICPMS, GC etc. USV Private Limited
  • FDA Proposes Landmark Drug Registration Reforms : What the New Rules Mean for Global Pharma and India
    11 July 2026
    FDA Proposes Landmark Drug Registration Reforms : What the New Rules Mean for Global Pharma and India

    The U.S. Food and Drug Administration (FDA) has proposed a major overhaul of its drug establishment registration and drug listing regulations, aiming to modernize oversight of pharmaceutical manufacturing and improve visibility across global supply chains. If finalized, the rule would introduce a new regulatory framework for distributed manufacturing and expand registration requirements for certain foreign drug manufacturing establishments that currently fall outside existing regulations.

  • FDA Pulls Up Lundbeck Over Allegedly Misleading Vyepti Migraine Promotion
    9 July 2026
    FDA Pulls Up Lundbeck Over Allegedly Misleading Vyepti Migraine Promotion

    The U.S. Food and Drug Administration (FDA) has issued a Letter to Lundbeck Seattle Biopharmaceuticals, alleging that promotional materials for its migraine treatment Vyepti (eptinezumab-jjmr) contained false or misleading claims that overstated the drug's benefits.

  • US FDA Approves Trutakna, a New Treatment for IgA Nephropathy to Reduce Proteinuria
    8 July 2026
    US FDA Approves Trutakna, a New Treatment for IgA Nephropathy to Reduce Proteinuria

    The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria (excess protein in the urine) in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval provides a new treatment option for patients with this rare kidney disease, which can eventually lead to kidney failure.

  • Vertex's CRISPR Gene Therapy CASGEVY Wins FDA Approval for Children as Young as 2 Years
    7 July 2026
    Vertex's CRISPR Gene Therapy CASGEVY Wins FDA Approval for Children as Young as 2 Years

    Vertex Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of CASGEVY (exagamglogene autotemcel), allowing its use in children 2 years of age and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises (VOCs) and transfusion-dependent beta thalassemia (TDT). The therapy was previously approved only for patients aged 12 years and older.

  • FDA Approves Tregzi, First Regulatory T-Cell Therapy to Reduce Chronic GVHD After Stem Cell Transplant
    1 July 2026
    FDA Approves Tregzi, First Regulatory T-Cell Therapy to Reduce Chronic GVHD After Stem Cell Transplant

    The U.S. Food and Drug Administration (FDA) has approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

  • Sandoz Moves Closer to Generic Tirzepatide Launch as US FDA Accepts ANDA Applications
    29 June 2026
    Sandoz Moves Closer to Generic Tirzepatide Launch as US FDA Accepts ANDA Applications

    US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.

    The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.

  • USFDA Completes Pre-License Inspection at Dr. Reddy's Bachupally Biologics Facility; Issues Form 483 with Seven Observations
    27 June 2026
    USFDA Completes Pre-License Inspection at Dr. Reddy's Bachupally Biologics Facility; Issues Form 483 with Seven Observations

    Dr. Reddy's Laboratories Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at the company's biologics manufacturing facility located in Bachupally, Hyderabad.

    According to the company's regulatory filing, the inspection was conducted from June 16 to June 25, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 containing seven observations.

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