• FDA Expands Finerenone Approval to Type 1 Diabetes-Linked Kidney Disease
    18 September 2026

    FDA Expands Finerenone Approval to Type 1 Diabetes-Linked Kidney Disease

    The U.S. Food and Drug Administration (FDA) has approved Kerendia (finerenone) for a new indication in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Bayer announced it as the first FDA-approved treatment option in more than 30 years for adults with CKD associated with type 1 diabetes
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    18 September 2026
    FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    Sanfilippo syndrome type A is a rare inherited disorder that primarily affects the brain and nervous system. Children with the condition can experience progressive loss of cognitive, language and other developmental abilities. Before this approval, there was no FDA-approved treatment specifically designed to address the underlying cause of MPS IIIA
  • FDA Launches Expedited IND Pilot to Speed First-in-Human Clinical Trials
    16 September 2026
    FDA Launches Expedited IND Pilot to Speed First-in-Human Clinical Trials

    The U.S. Food and Drug Administration (FDA) has launched a new Expedited Investigational New Drug (IND) Pilot Program aimed at reducing the time required to move promising drug candidates from development into first-in-human (FIH) clinical trials in the United States.

    Under the pilot, drug sponsors will partner with Qualified Research Institutions (QRIs), which can include academic medical centers, contract research organizations, health networks and other research organizations with relevant scientific and regulatory expertise.

  • Alembic Pharma Completes USFDA Inspection Without Form 483 Observations
    11 September 2026
    Alembic Pharma Completes USFDA Inspection Without Form 483 Observations
    Alembic Pharmaceuticals Limited has successfully completed an unannounced onsite inspection conducted by the United States Food and Drug Administration (USFDA) at its Bioequivalence Facility in Vadodara, Gujarat.
  • FDA Approves Zanvastro, First Targeted Treatment for Rare Alexander Disease
    5 September 2026
    FDA Approves Zanvastro, First Targeted Treatment for Rare Alexander Disease

    The U.S. Food and Drug Administration (FDA) has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients, marking the first FDA-approved therapy for this rare and progressive neurological disorder.

  • FDA Warns Fresenius Medical Care Over Leaking Dialysis Bags and Manufacturing Control Failures
    4 September 2026
    FDA Warns Fresenius Medical Care Over Leaking Dialysis Bags and Manufacturing Control Failures

    The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Medical Care AG & Co. KGaA, citing significant Current Good Manufacturing Practice (CGMP) violations at its Ogden, Utah manufacturing facility.

  • FDA Raises Fresh Safety Concerns Over Unapproved GLP-1 Weight-Loss Drugs
    3 September 2026
    FDA Raises Fresh Safety Concerns Over Unapproved GLP-1 Weight-Loss Drugs

    The U.S. Food and Drug Administration (FDA) has issued a detailed warning about the risks associated with unapproved and compounded GLP-1 drugs being used for weight loss, highlighting concerns related to product quality, dosing errors, counterfeit medicines and improper storage.

  • FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
    30 August 2026
    FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder

    The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular issues, such as blood clots, stroke and heart attack.

  • FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
    30 August 2026
    FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults

    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya offers patients an important new alternative by providing an effective oral treatment option.

  • USFDA Inspection at Aurobindo Pharma’s Lannett Facility Concludes With Four Observations
    24 August 2026
    USFDA Inspection at Aurobindo Pharma’s Lannett Facility Concludes With Four Observations

    A routine inspection by the United States Food and Drug Administration (US FDA) at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma USA, Inc., has concluded with four observations.

    The inspection was conducted at Lannett Company’s manufacturing facility in Seymour, Indiana, USA, from August 17 to August 21, 2026. According to the company’s regulatory filing, the inspection was carried out as part of the US FDA’s routine inspection process.

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