• FDA Approves Second Treatment for Rare “Stone Man” Disease
    20 August 2026

    FDA Approves Second Treatment for Rare “Stone Man” Disease

    The U.S. Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) as a treatment for adults with fibrodysplasia ossificans progressiva (FOP), an extremely rare genetic disorder in which muscles, tendons and ligaments can gradually turn into bone. The approval makes Pasatru the second FDA-approved treatment for FOP, providing another therapeutic option for people affected by this debilitating condition.

  • Dr. Reddy’s Wins U.S. FDA Approval for Rituximab Biosimilar, Strengthening Global Biologics Presence
    4 August 2026
    Dr. Reddy’s Wins U.S. FDA Approval for Rituximab Biosimilar, Strengthening Global Biologics Presence

    Dr. Reddy’s Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan® (rituximab), marking another significant milestone in the company's expanding global biosimilars business.

    The approval enhances Dr. Reddy’s biologics portfolio and reinforces its presence in the highly regulated U.S. pharmaceutical market. The biosimilar was developed, manufactured, and submitted for approval entirely by Dr. Reddy’s Laboratories.

  • FDA Flags Viatris' TOBI Podhaler Promotional Video for Misleading Usage Claims
    1 August 2026
    FDA Flags Viatris' TOBI Podhaler Promotional Video for Misleading Usage Claims

    The U.S. Food and Drug Administration (FDA) has issued an Untitled Letter to Viatris Specialty LLC, stating that a direct-to-consumer (DTC) promotional video for TOBI® PODHALER® (tobramycin inhalation powder) contains false or misleading claims regarding the product's use. According to the FDA, the promotional material misbrands the drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

  • FDA Approves First 12-Hour OTC Pain Relief Tablet Combining Acetaminophen and Naproxen
    25 July 2026
    FDA Approves First 12-Hour OTC Pain Relief Tablet Combining Acetaminophen and Naproxen

    The U.S. Food and Drug Administration (FDA) has approved Tylenol with Naproxen, the first nonprescription fixed-dose combination of acetaminophen and naproxen sodium for up to 12 hours of pain relief. The approval introduces a new over-the-counter (OTC) option for consumers seeking long-lasting, dual-action pain management without a prescription.

  • 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.

  • US FDA Issues Warning Letter to Alembic Pharmaceuticals Over Clinical Study Consent Process
    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.
  • FDA Issues Form 483 to Catalent Indiana Over Sterile Drug Manufacturing Concerns
    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.
  • 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.
Subscribe to USFDA