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Clinical courses

 

Clinical research courses

  • Johnson & Johnson receives approval from USFDA and European Commission for SIRTURO (bedaquiline)

    Johnson and Johnson announced that the US Food and Drug Administration has issued traditional approval for SIRTURO bedaquiline as part of combination therapy in adult and pediatric patients 5 years and older and weighing at least 15 kg with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid
  • US lawmakers probe USFDAs inspection in India and China
    US lawmakers probe USFDAs inspection in India and China where they found many variations in inspection outcomes. In a new letter to Food and Drug Administration (FDA) Commissioner Robert Califf, House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith are pressing for more information regarding the agency’s foreign drug inspection program.
  • FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

    The Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

  • Alembic Pharmaceuticals announces USFDA approval for Icatibant Injection
    Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Icatibant Injection
  • Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules USP,
    Glenmark has received final approval by the United States Food and Drug Administration USFDA for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), determined by the FDA to be bioequivalent1 to Nexium.
  • Zydus receives final approval from USFDA for Dapsone Gel, 7.5%

    Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD : Aczone® Gel 7.5%). 

    Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). 

    Dapsone Gel, 7.5% had annual sales of USD 35.8 mn in the United States (IQVIA MAT March 24).

  • FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
    Patients were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every 3 weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression.
  • FDA approves first drug for WHIM syndrome
    WHIM syndrome is a rare genetic disease that causes the body’s immune system to not function properly. WHIM syndrome reduces the number of mature neutrophils and lymphocytes (types of white blood cells important in fighting infection) circulating within the body. It is estimated to occur in about 1 in 5 million live births. Approximately 60 cases have been reported in the medical literature.
  • USFDA approves Pfizer’s BEQVEZ
    BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.
  • Novartis radioligand therapy Lutathera FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors
    Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer.
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