• FDA Approves HOVILPRI (Pritelivir), a New Oral Treatment for Difficult-to-Treat Herpes Infections
    10 October 2026

    FDA Approves HOVILPRI (Pritelivir), a New Oral Treatment for Difficult-to-Treat Herpes Infections

    The U.S. Food and Drug Administration (FDA) has approved HOVILPRI (pritelivir) tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection in immunocompromised adults whose infections have not responded to standard antiviral treatments.
  • FDA Approves Novartis’ Rhapsido as First Treatment Specifically for Symptomatic Dermographism
    8 October 2026
    FDA Approves Novartis’ Rhapsido as First Treatment Specifically for Symptomatic Dermographism
    The U.S. Food and Drug Administration (FDA) has approved Novartis’ Rhapsido® (remibrutinib) for adults with symptomatic dermographism (SD) whose symptoms are not adequately controlled with H1 antihistamines, making it the first FDA-approved treatment specifically for the condition.
  • FDA Approves First Heart Valve Designed to Grow with Children
    2 October 2026
    FDA Approves First Heart Valve Designed to Grow with Children
    The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. This innovative device may reduce the need for repeat open-heart surgeries in children with heart defects, reflecting the Trump Administration’s commitment to bringing breakthrough medical technologies to market as quickly and safely as possible.
  • FDA Flags Major GMP Violations at Fresenius Kabi Sterile Injectable Facility; Recalls and Corrective Actions Under Review
    2 October 2026
    FDA Flags Major GMP Violations at Fresenius Kabi Sterile Injectable Facility; Recalls and Corrective Actions Under Review
    The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi USA LLC over significant Current Good Manufacturing Practice (CGMP) violations identified at the company's sterile drug manufacturing facility in Melrose Park, Illinois.
  • AbbVie’s JUVMO Gets FDA Approval for Parkinson’s Disease: New D1/D5 Targeted Treatment Approved in the U.S.
    29 September 2026
    AbbVie’s JUVMO Gets FDA Approval for Parkinson’s Disease: New D1/D5 Targeted Treatment Approved in the U.S.

    AbbVie’s JUVMO (tavapadon) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease in adults. The once-daily oral medicine introduces a different approach to dopamine-based treatment by selectively targeting D1/D5 receptors.

    AbbVie announced on September 28, 2026, that the FDA approved JUVMO tablets for adults with Parkinson’s disease. The company describes JUVMO as the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease.

  • 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.

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