Approvals

Categories
  1. 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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  2. Leukemia

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

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

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

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  5. Lymphoma

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

    The FDA has approved a new HIV treatment for patients with limited treatment options.
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  7. Breast cancer

    The Food and Drug Administration (FDA) have extended the approval of Verzenio (abemaciclib) to now be a first line treatment for some types of advanced or metastatic breast cancer.
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  8. Parkinson’s disease

    FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions. 
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  9. Lung cancer

    Imfinzi (durvalumab), already approved for some bladder cancers, is now FDA approved for some patients with lung cancer.
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  10. Prostate cancer

    The FDA has approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy.
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  11. MS

    The Scottish Medicines Consortium (SMC) has approved Mavenclad (cladribine) as a treatment for highly active relapsing multiple sclerosis.
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  12. Autism

    The experimental drug from Roche (balovaptan) has now been given Breakthrough Therapy Designation, potentially placing the drug on a faster path to market as the first pharmacological treatment for autism spectrum disorder (ASD). Pharmatimes, 30/01/2018.
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  13. Digestive tract cancer

    Following the EMA’s approval in late 2017, the FDA has now also approved Lutathera (lutetium Lu 177 dotatate) for certain digestive tract cancers.
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  14. What are the latest breakthroughs in multiple sclerosis (MS)?

    The potential of neuroprotective agents for a whole new form of treatment.

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  15. Lymphoma

    Brentuximab vedotin (Adcetris) has now been approved by the European Commission for the treatment of patients with CD30-positive cutaneous T-cell lymphoma (CTCL) who have had at least 1 prior systemic therapy.
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  16. Multiple sclerosis

    Ocrevus (ocrelizumab), the first ever FDA approved medicine for primary progressive MS has now also been approved by the EMA.
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  17. Spinraza, the new medicine for spinal muscular atrophy

    Is there substance to the claims that it's a groundbreaking treatment?

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  18. Biosimilars

    The FDA has approved the first biosimilar for the treatment of certain breast and stomach cancers.
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  19. Lung cancer

    A phase 3 study on lung cancer showed that Imfinzi (durvalumab) as a consolidation therapy reduced the risk of the disease progressing by 48 percent.
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  20. HIV/AIDS

    FDA approves Juluca (dolutegravir and rilpivirine) for the maintenance treatment of certain patients with HIV-1 infection.
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  21. A new medicine for Alzheimer's disease?

    Introducing a breakthrough known as 'CT1812'

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  22. Defining ocrelizumab's role within the MS treatment landscape

    Ocrevus (ocrelizumab) was approved in the US by the FDA in March 2017 for the treatment of adults with relapsing or primary progressive forms of MS, based on three clinical trials.

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  23. Edaravone availability in the US - one month to go

    As we await the arrival of edaravone to US pharmacies, patients can access edaravone now through TheSocialMedwork.edaravone best price

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  24. Accessing edaravone in your country - the new FDA approved drug for ALS

    What are the results from the clinical studies that led to the approval of edaravone, and how can patients access it in their country?

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  25. Radicava/Radicut (edaravone) for ALS

    For the first time in 22 years, the US Food and Drug Administration (FDA) has approved a drug to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease; a motor neuron disease characterised by muscular atrophy and weakness.
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  26. Nivolumab Dominates the News

    Promising Results from Multiple Studies

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  27. Daratumumab approved as multiple myeloma treatment

    The FDA approval of a promising new drug is offering new hope to multiple myeloma patients who have already been through various treatments. 

    Daratumumab multiple myeloma treatment

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  28. Alectinib approved for the treatment of ALK-positive NSCLC

    A new treatment that targets a specific type of lung cancer has received FDA approval. 

    Alectinib treatment ALK-positive NSCLC

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  29. Edaravone approved in Japan for the treatment of ALS

    The Pharmaceutical and Medical Device Agency (PMDA), has granted marketing approval for the use of Edaravone for the treatment of ALS in Japan.

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