• FDA approves First Generic Dapagliflozin Tablets
    U.S. Food and Drug Administration approved the first generics of FARXIGA (dapagliflozin) tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Lilly's novel weight loss medicine gets FDA approval

    Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems.

    When used alongside a reduced-calorie diet and increased physical activity, Foundayo helps individuals lose excess body weight and keep the weight off. Foundayo will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers.

  • Novo Nordisk : Awiqli® approved in the USA
    Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes.
  • 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.

  • 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.

  • 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
  • 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.

  • 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.
  • 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.

  • 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
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