Approvals

Categories
  1. Newly approved medicines for Cystic Fibrosis

    Here is an overview of each medicine to help guide you and your physician when making a treatment decision for Cystic Fibrosis: 

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  2. New Parkinson's therapy approved by the FDA

    Kyowa Hakko Kirin's Parkinson's therapy, Nourianz (istradefylline), gains FDA approval as an add-on to levodopa/carbidopa.

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  3. China approves edaravone for ALS

    Radicut/Radicava (edaravone), shown to slow the progression of ALS, is now approved for patients in China.

    China flag thumbs-uo hand gesture

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  4. SMC rejects two cystic fibrosis drugs

    Orkambi and Symkevi have been rejected by the Scotland Medicines Consortium (SMC) due to their conclusion that the costs outweigh the benefits.

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  5. EMA recommends approval of Vitrakvi (larotrectinib)

    Vitrakvi (larotrectinib) recommended by the CHMP for approval in the EU.

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  6. Libtayo (cemiplimab): The only EU approved treatment for advanced CSCC

    New skin cancer medicine now approved in the EU for adults with metastatic or locally advanced cutaneous squamous cell carcinoma.

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  7. Vyndaqel (tafamidis): Amyloidosis treatment approved by the FDA

    Vyndaqel (tafamidis) is now approved in the U.S. after study showed increased survivorship rate and reduced hospital time due to heart related problems.

    US flag thumbs up gesture

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  8. FDA gives go-ahead for MN166 (ibudilast) to begin phase 2b/3 clinical trials

    Approval for next phase of clinical trials puts ALS patients one step closer to accessing new treatment shown to slow disease progression.

    FDA Ibudilast molecule and pills

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  9. Kalydeco (ivacaftor) now approved in Canada for children aged 1-2

    Based on promising results from phase III clinical trials, Health Canada has decided to extend the use of Kalydeco (ivacaftor) to include children aged 1 to 2 years. 

    toddler in park with bubles

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  10. Children with cystic fibrosis have a chance to breathe easier

    A recent clinical trial indicates that Symkevi/Symdeko (tezacaftor/ivacaftor) can safely and effectively loosen thick, sticky mucus for children 6-11 years old.

    girl running through field

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  11. New study supports FDA's decision to approve Copiktra (duvelisib)

    Phase III trial shows that Copiktra (duvelisib) may be an option for patients with relapsed or refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma.

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  12. Onpattro (patisiran): the first RNAi therapeutic approved in the European Union

    Onpattro (patisiran) is a first-in-class treatment that slows down the progression of hereditary transthyretin amyloidosis (hATTR).

    EU approval OK hand gesture

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  13. Erleada (apalutamide) gets positive opinion from the EMA

    New medicine shows statistically significant improvements for prostate cancer patients.

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  14. Orkambi approved in Australia, will others follow?

    Australia provides reimbursement for cystic fibrosis medicine.

    family blowing bubbles

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  15. Alunbrig (brigatinib) approved in Europe for another type of lung cancer

    The European Commission has approved Alunbrig (brigatinib) for the treatment of a specific type of lung cancer.

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  16. Newly approved in the EU: Durvalumab (Imfinzi) an immunotherapy for Stage III Lung Cancer

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  17. CAR T cell approval may offer patients a new form of therapy

    Industry NewsAccording to study investigators, about a third of patients could benefit from this therapy that may offer remissions, relieve symptoms and save lives.

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  18. 2018 - Good year for new FDA approvals of cancer treatments

    2018 has been a good year for new cancer treatments says the U.S. AACR. 
    AACR news 

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  19. Kisqali (ribociclib) approved for additional indications in HR+/HER2- advanced breast cancer

    News updateKisqali is now the only CDK4/6 inhibitor for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the US.

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  20. In-depth review of the new EMA-approved preventative migraine injection

    The approval marks a significant advance in the field of neurology — and one that migraine patients will no doubt welcome.

    News update


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  21. Erenumab (Aimovig) now approved for the European Union

    The new preventive medicine for migraine Aimovig (erenumab) has been approved by the EMA. Read more...
    Breaking News 

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  22. FDA grants accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for metastatic colorectal cancer

    Industry News

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  23. Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations

    Industry News

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  24. Full marketing authorisation for blinatumomab

    Industry NewsThe latest approval renders the previous 'temporary approval' a full approval, without further results needed.

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  25. 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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  26. Keytruda (pembrolizumab) given accelerated approval for cervical cancer

    industry news

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  27. 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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  28. 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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  29. 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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  30. Preapproval vs unapproved or elsewhere approved medicines

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

    preapproval vs unapproved

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