Approvals

  1. A wearable device for opioid withdrawal?

    Industry NewsThe FDA has approved a wearable device to treat withdrawal symptoms such as agitation, anxiety, depression, and opiate cravings.

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  2. Keytruda (pembrolizumab) given accelerated approval for cervical cancer

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  3. Tagrisso gets the green light for first-line lung cancer treatment in Europe

    Industry NewsTagrisso (osimertinib) has been approved in Europe to treat Epidermal Growth Factor Receptor (EGFR) mutated non-small cell lung cancer (NSCLC) as a first-line treatment. 

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  4. Xeljanz (tofacitinib) approved for treatment of ulcerative colitis

    This will provide a much-needed alternative therapy for a debilitating disease with limited treatment options. 

    Industry News

    Moderately to severely active ulcerative colitis can now be treated with Xeljanz (tofacitinib), following the expanded approval by the Food and Drug Administration (FDA). This will provide a much-needed alternative therapy for a debilitating disease with limited treatment options.

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  5. More information available to psoriasis patients in new label update

    This new development may increase chances of patients discussing the disease with their doctor...

    Industry News

    A new package insert that includes information/data about psoriasis in the genital area has been approved by the Food and Drug Administration (FDA). 

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  6. New prostate cancer medication offers the same treatment with fewer side effects

    Men with metastatic castration-resistant prostate cancer (mCRPC) may have a new course of treatment available to them.

    TSM News Stock

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  7. Preapproval vs unapproved or elsewhere approved medicines

    ‘Unapproved medicines’, ‘compassionate use’, ‘early access drugs’..

    preapproval vs unapproved

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  8. Ovarian cancer

    Rubraca (rucaparib), already approved as a treatment for BRCA positive ovarian cancer, has been approved as a maintenance therapy for ovarian cancer regardless of BRCA mutation. 
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  9. Leukemia

    The FDA approves Blincyto (blinatumomab) for patients with B-cell ALL, who are in remission but still have minimal residual disease.
    leukemia

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  10. Pediatric leukemia

    FDA approves Tasigna (nilotinib) for certain pediatric patients with Ph+ CML in chronic phase.
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  11. Diabetic retinopathy

    FDA approves Genentech’s Lucentis (ranibizumab injection) syringe for diabetic macular edema and diabetic retinopathy.

    FDA

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  12. Lymphoma

    FDA expands approval of Adcetris (brentuximab vedotin) for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy.
    Industry news

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