• Cipla receives USFDA approval for First AB-Rated Generic of Ventolin HFA
    24 April 2026

    Cipla receives USFDA approval for First AB-Rated Generic of Ventolin HFA

    Cipla Limited and its wholly owned subsidiary Cipla USA Inc., announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation from the United States Food and Drug Administration (USFDA). It is the first AB–rated generic therapeutic equivalent of Ventolin® HFA, marketed by GlaxoSmithKline.

  • 24 April 2026
    Regeneron Pharma announced approval for Otarmeni

    Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni™ (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program.

  • 8 April 2026
    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.
  • 2 April 2026
    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.

  • 27 March 2026
    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.
  • 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.
Subscribe to USFDA