• FDA Clears First Daily Oral PCSK9 Pill for High Cholesterol
    17 July 2026

    FDA Clears First Daily Oral PCSK9 Pill for High Cholesterol

    Merck has announced that the US Food and Drug Administration (FDA) has approved LIPFENDRA® (enlicitide) 20 mg, making it the first and only once-daily oral PCSK9 inhibitor for lowering low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). The approval marks the first oral alternative to injectable PCSK9 inhibitors.

  • FDA Grants Full Approval to Novartis' Fabhalta for IgA Nephropathy
    17 July 2026
    FDA Grants Full Approval to Novartis' Fabhalta for IgA Nephropathy

    Novartis has announced that the US Food and Drug Administration (FDA) has granted traditional approval to Fabhalta® (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The decision follows the drug's accelerated approval in August 2024, which was based on its ability to reduce proteinuria.

  • FDA Approves First Generic Afatinib Tablets for Lung Cancer; Apotex and Hetero Secure U.S. Approval
    15 July 2026
    FDA Approves First Generic Afatinib Tablets for Lung Cancer; Apotex and Hetero Secure U.S. Approval
    The U.S. Food and Drug Administration (FDA) has approved the first generic versions of GILOTRIF (afatinib) tablets, marking an important milestone in expanding access to targeted therapy for patients with specific forms of non-small cell lung cancer (NSCLC). The approval covers generic afatinib tablets manufactured by Apotex Inc. and Hetero Labs Limited Unit V.
  • 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.

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