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  • Biocon Pharma Secures USFDA Approval for Everolimus Tablets for Oral Suspension
    12 January 2026

    Biocon Pharma Secures USFDA Approval for Everolimus Tablets for Oral Suspension

    Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension. The approval covers 2 mg, 3 mg and 5 mg strengths.

  • 6 January 2026
    FDA nods first pediatric therapy for rare blood disorder aTTP

    The U.S. Food and Drug Administration has approved Cablivi (caplacizumab-yhdp) for pediatric patients 12 years and older suffering from acquired thrombotic thrombocytopenic purpura (aTTP), marking the first time a treatment has been authorized for this extremely rare condition in children.

  • 6 January 2026
    ScinoPharm gets U.S. FDA approval for Multiple Sclerosis treatment
    ScinoPharm Taiwan has clinched a landmark regulatory victory by securing U.S. Food and Drug Administration (FDA) approval for its Glatiramer Acetate Injection, a treatment used to manage multiple sclerosis (MS), the company announced
  • 3 January 2026
    Axsome Therapeutics secures FDA priority review for Alzheimer’s agitation treatment AXS-05

    Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AXS-05 seeking approval for the treatment of agitation associated with Alzheimer’s disease, and has granted Priority Review designation to the filing. The regulatory body has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026, underlining the importance of this potential new therapy in an area of high unmet need.

  • 23 December 2025
    Novo Nordisk Receives USFDA approval for Wegovy pill in the US
    Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction long term and to reduce the risk of major adverse cardiovascular events.
  • 5 December 2025
    FDA approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
    The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy.
  • 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.
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