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  • US FDA Warns Almon Healthcare Over Serious API GMP Lapses
    24 July 2026

    US FDA Warns Almon Healthcare Over Serious API GMP Lapses

    The U.S. Food and Drug Administration (US FDA) has issued a Warning Letter to Almon Healthcare Private Limited, Ahmedabad, Gujarat, after identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations at its active pharmaceutical ingredient (API) manufacturing facility during an inspection conducted from February 9–13, 2026. The warning letter was issued on July 13, 2026.

  • 22 July 2026
    US FDA Issues Warning Letter to Alembic Pharmaceuticals Over Clinical Study Consent Process
    The US Food and Drug Administration (FDA) has issued a Warning Letter to Alembic Pharmaceuticals Ltd. after identifying deficiencies during an inspection of the company's bioequivalence research facility in Vadodara, Gujarat. The inspection was conducted between March 3 and March 7, 2025, as part of the FDA's Bioresearch Monitoring Program.
  • 18 July 2026
    FDA Issues Form 483 to Catalent Indiana Over Sterile Drug Manufacturing Concerns
    The U.S. Food and Drug Administration, FDA has issued a Form FDA 483 to Catalent Indiana LLC. The inspection identified multiple observations related to quality systems, contamination control, investigations, and sterile manufacturing practices at the facility.
  • 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.

  • 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.

  • 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.
  • 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.

  • 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.

  • 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
  • 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.

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