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    Home > Medical News > Medical World News > The FDA rejected the application for a new drug for tramadol intravenously because of its safety.

    The FDA rejected the application for a new drug for tramadol intravenously because of its safety.

    • Last Update: 2020-10-23
    • Source: Internet
    • Author: User
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    2020.10.13 Research and Development NEWS Lilly and Johnson and Johnson announce the latest clinical results of IL-23 inhibitors for the treatment of Crohn's disease; We focus on the latest developments in pharmaceutical research and development, to provide research and development personnel with timely and accurate information reference.
    (click on the title, read the original article) After the Oxford vaccine, the Johnson and Johnson New Crown Vaccine study was suspended due to unexplained symptoms of the participants, according to the U.S. health media STAT website reported that one study participant developed an unexplained disease, Johnson and Johnson's new crown vaccine research has been suspended.
    and Johnson and Johnson announce the latest clinical results of IL-23 inhibitors for crohn's disease! The UEG Week 2020 virtual meeting was held from October 11-13, and Lilly and Johnson and Johnson announced the latest results of two phase 2 clinical studies of IL-23 inhibitors mirikizumab and Tremfya for Crohn's disease.
    results showed that mirikizumab was treated for 52 weeks, resulting in continuous improvement of symptoms in patients with moderate to severe active CD and a significant reduction in inflammation of the intestinal mucosa, and in patients with moderate to severe active CD, Tremfya showed significant improvement in key clinical and endoscopic outcome indicators compared to placebo, with safety consistent with approved adaptation.
    13th successful Phase III study on the treatment of moderate severe asthma in children, Sanofi announced that its Dupilumab has reached the primary and critical secondary endpoints in a critical Phase III clinical trial for the treatment of moderate severe asthma in children aged 6-11 years.
    Dupixent is also the only biologic agent currently shown to improve lung function in children in a randomized Phase III study.
    Gilead JAK1 inhibitor Phase 2b/3 clinical results actively provide continuous remission to UC patients Today, Gilead and Galapagos jointly announced that the oral JAK1 selective inhibitor filgotinib, jointly developed by the two companies, demonstrated long-lasting efficacy and safety in the treatment of stage 2b/3 clinical trials for moderate active ulcerative colitis (UC).
    patients treated with 200 mg filgotinib achieved clinical remission at week 10 and maintained remission until week 58 compared to placebo.
    : The FDA rejected a new drug application for tramadol intravenous agents because of safety, Avenue released the full FDA response letter on tramado intravenous agents.
    The FDA decided not to approve the drug's current form of market application, even though the key Phase 3 clinical trial of the quemado intravenous drug proved that it reached all major and multiple secondary endpoints, showing statistically significant results.
    first innovative NASH therapy in five years was recognized by the FDA for breakthrough therapies Today, Inventiva announced that the FDA has awarded the company's leading drug candidate, Lanifibranor Breakthrough Therapy, for the treatment of non-alcoholic fatty hepatitis (NASH).
    , Lanifibranor is the first NASH candidate to be awarded this recognition since January 2015, according to a press release.
    Oshitini's new adaptive disease listing application in China is to be included in the priority review on the 12th, AstraZeneone in China submitted the application for the listing of meth sulfonate Ocitini tablets is to be included in the priority review, for non-small cell lung cancer adult patients with skin growth factors sensitive mutations after tumor excision.
    Fosun Pharma Avaquopa tablet new adaptive disease approved to start the recent Phase III clinical 13th, Fosun Pharma announced that the introduction of its new drug "Malay acid avalanthepa tablets" was approved by NMPA to carry out clinical trials for adult chronic immunocompetitive plateroid reduction adhesive disorders.
    Pharma intends to conduct phase III clinical trials in China after the near-term conditions are in place.
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