• AstraZeneca’s All-Oral Calquence Combo Wins US FDA Approval
    23 February 2026

    AstraZeneca’s All-Oral Calquence Combo Wins US FDA Approval

    AstraZeneca announced that the U.S. Food and Drug Administration has approved its fixed-duration all-oral combination of Calquence® (acalabrutinib) with venetoclax for the first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adults. The approval marks the first time a Bruton’s tyrosine kinase (BTK) inhibitor-based regimen has been authorised in the U.S. as a time-limited, oral treatment option for newly diagnosed patients.

  • 6 February 2026
    AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®)
    The regulatory submissions to the FDA and EMA are supported by previously announced results from the Viti-Up studies evaluating the safety and efficacy of upadacitinib in patients with NSV.
  • 21 January 2026
    FDA warns Genetrace for selling HIV Test without Approval

    The U.S. Food and Drug Administration (FDA) has issued an official warning letter to Genetrace, a company based in Blaine, Washington, for offering an HIV diagnostic self-collection kit to U.S. customers without proper authorization.

    According to the FDA, the product in question is a dried blood spot (DBS) card self-collection kit that people use at home to collect blood samples and send them to a lab for HIV testing. The agency says this kit qualifies as a medical device because it is meant to help diagnose disease.

  • 15 January 2026
    FDA issues Warning Letter to Indian Clinical Investigator over Bioequivalence Study Violations
    The U.S. Food and Drug Administration (FDA) has issued a formal warning letter to a clinical investigator at Senthil Specialty Hospital in Pondicherry, India, citing significant violations of federal regulations during a clinical bioequivalence study
  • 15 January 2026
    FDA and EU unveil unified principles to guide AI’s role in Drug Discovery and Development
    U.S. Food and Drug Administration in collaboration with the European Medicines Agency EMA, has released a set of Guiding Principles for Good AI Practice in Drug Development
  • 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.
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