• FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
    27 March 2026

    FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I

    The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant.

  • 6 March 2026
    FDA Approves New Combination Therapy for Relapsed or Refractory Multiple Myeloma

    The U.S. Food and Drug Administration has approved a new treatment combination of teclistamab‑cqyv with daratumumab and hyaluronidase‑fihj for adult patients with relapsed or refractory Multiple Myeloma. The approval offers a new therapeutic option for patients whose disease has returned or stopped responding after earlier treatments.

  • 5 March 2026
    US FDA Approves Glenmark’s Generic Fluticasone Propionate Inhaler for Asthma Treatment
    Glenmark Specialty SA has received final approval from the U.S. Food and Drug Administration for Fluticasone Propionate Inhalation Aerosol USP
  • 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.

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