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    Home > Medical News > Medical World News > In December, 5 innovative drugs may be approved for marketing!

    In December, 5 innovative drugs may be approved for marketing!

    • Last Update: 2022-12-29
    • Source: Internet
    • Author: User
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    In November, the FDA approved a total of 5 new drugs, including Tzield, the world's first innovative anti-diabetes delaying therapy, Hemgenix, the first hemophilia B gene therapy, Sezaby (phenobarbital sodium), the anti-tumor ADC drug ElahereTM, and the CTLA-4 monoclonal antibody Imjudo (tremelimumab).

    Looking forward to December, some institutions predict that another 5 innovative drugs may be approved by the US FDA
    .
    Toripalimab and Coherus' toripalimab are anti-PD-1 monoclonal antibodies that specifically bind to PD-1 molecules on the surface of T cells, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, and reactivating the anti-tumor activity of lymphocytes to treat cancer
    。 The drug has received priority review from the FDA for two indications: first, in combination with gemcitabine and cisplatin for first-line treatment in patients with advanced recurrent or metastatic nasopharyngeal carcinoma; The second is as a single agent for the second-line or late-stage treatment
    of patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed to platinum-containing chemotherapy or disease progression after chemotherapy.
    Lenacapavir of Gilead Sciences applied to the FDA for approval to treat infections in patients with multidrug-resistant (MDR) HIV-1 infection with severe treatment experience (HTE
    ).
    Enacapavir is an HIV-1 cap inhibitor administered by medical professionals and injected
    subcutaneously every six months along with other antiretroviral drugs.
    Lenacapavir seeks approval on the basis of the clinical trial CAPELLA, a Phase 2/3 placebo-controlled study that met the primary endpoint
    .
    Specifically, the FDA received the drug's resubmitted NDA application in July this year, and the PDUFA date is set for December 27
    , 2022.
    Ublituximab TG Therapeutics' Ublituximab is indicated for multiple sclerosis (MS), a sugar-engineered monoclonal antibody that targets a unique epitope
    on the CD20 antigen expressed by B cells.
    The FDA is reviewing paclitaxel
    used by TG Therapeutics to treat recurrent multiple sclerosis.
    TG's application is based on two Phase III clinical trials, ULTIMATE 1 and ULTIMATE 2, evaluating annual recurrence rate (ARR) as its primary endpoint, seeking approval
    .
    Palovarotene is indicated for progressive muscular ossification by Ipsen, a selective retinoic acid receptor γ (RARγ) agonist
    .
    The FDA received the NDA application for the drug and granted it priority review status at the end of June this year, with a PDUFA date set for December 29
    , 2022.
    The FDA granted Ipsen/Clementia's palovarotene priority review
    for the prevention of ectopic ossification (new bone formation) in patients with fibrodysplasia (FOP).
    Palovarotene is seeking approval based on an open-label, phase 3 single-treatment trial in which all subjects received doses of palovarotene to evaluate safety and dosing regimens
    .
    Mosunetuzumab mosunetuzumab, a Roche genentech company, is indicated for follicular lymphoma (FL), a T-cell artigated bispecific antibody
    that targets the CD20 antigen on the surface of B cells and the CD3 receptor on the surface of T cells.
    The FDA received the drug's BLA application and granted priority review status in early July this year, and the PDUFA date is set for December 29
    , 2022.
    The FDA granted Genentech's mosunetuzumab priority review rights for the treatment of relapsed or refractory follicular lymphoma (FL) in adult patients who had previously received at least two systemic treatments
    .
    Follicular lymphoma, an indolent (slow-growing) form of common non-Hodgkin lymphoma (NHL), is a type of blood cancer that often recurs
    after initial treatment.
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    to anyone.
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