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  • FDA Introduces New Guidance to Streamline Biosimilar Development and Cut Drug Costs
    5 November 2025

    FDA Introduces New Guidance to Streamline Biosimilar Development and Cut Drug Costs

    The U.S. Food and Drug Administration (FDA) has announced new measures aimed at accelerating the development of biosimilar medicines and lowering the overall cost of biologic treatments in the United States.
  • 4 November 2025
    Zydus receives tentative nod from USFDA for Budesonide capsules
    Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg).
  • 4 November 2025
    FDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial disease

    The U.S. Food and Drug Administration (FDA) approved Kygevvi (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients who start to show symptoms when they are 12 years old or younger. Kygevvi received Breakthrough Therapy Designation for this indication.

  • 3 November 2025
    FDA Takes Action to Protect Children from Unapproved Fluoride Medications
    The U.S. Food and Drug Administration today announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The FDA sent notices to four companies outlining the agencys intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay.
  • 27 October 2025
    Blenrep approved by USFDA for use in treatment of relapsed/refractory multiple myeloma
    GSK plc announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
  • 11 October 2025
    FDA Confirms DEG / EG contaminated cough syrups in India, Not exported to U.S.
    The U.S. Food and Drug Administration (FDA) has acknowledged reports of severe and ongoing contamination involving diethylene glycol (DEG) and ethylene glycol (EG) in children’s cough and cold medicines in India. The agency confirmed that these contaminated products have not been shipped to the United States.
  • 9 October 2025
    Lupin Unveils Strategic Partnership Program to Expand Reach of its Long-Acting Injectable Platform
    PrecisionSphere™ demonstrates efficacy and safety in drug delivery and is ready for commercial use, following the recent United States Food and Drug Administration’s (U.S. FDA) approval for the first product developed with this platform.
  • 23 September 2025
    FDA rejects Otsuka and Lundbeck’s bid for REXULTI® in PTSD Treatment
    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for the use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
  • 23 September 2025
    FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
    U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria.
  • 23 September 2025
    FDA moves to approve Leucovorin Calcium for rare neurological disorder linked to Autism

    The U.S. Food and Drug Administration (FDA) has taken a significant step forward in approving leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD) — a rare neurological condition that disrupts the transport of folate, a vitamin essential for brain development and function.

    Cerebral folate deficiency has been associated with developmental delays, seizures, coordination problems, and autistic features such as challenges in social communication, sensory issues, and repetitive behaviors.

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