• FDA Approves Genentech’s Tecentriq for Precision-Guided Bladder Cancer Treatment
    16 May 2026

    FDA Approves Genentech’s Tecentriq for Precision-Guided Bladder Cancer Treatment

    Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq and Tecentriq Hybreza for the adjuvant treatment of adults with muscle-invasive bladder cancer (MIBC) who show circulating tumor DNA molecular residual disease (ctDNA MRD) after bladder removal surgery. The approval marks the first FDA-cleared ctDNA-guided therapy approach for this aggressive cancer type.

  • 15 May 2026
    FDA launches major push to repurpose existing drugs for rare and chronic diseases

    The U.S. Food and Drug Administration (FDA) has announced a new initiative aimed at accelerating the repurposing of already approved medicines to treat diseases with significant unmet medical needs, including rare disorders, neurodegenerative diseases, metabolic conditions, and substance use disorders.

  • 14 May 2026
    FDA Approves BeOne’s BEQALZI for Blood Cancer
    BeOne Medicines Ltd. a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma
  • 7 May 2026
    BIZENGRI Receives FDA National Priority Voucher for NRG1+ Cholangiocarcinoma

    Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

  • 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.

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