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FDA approves first generics of Gilenya
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05 December 2019 |
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FDA approves novel treatment to target abnormality in sickle cell disease
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25 November 2019 |
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FDA approves first treatment for inherited rare disease
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20 November 2019 |
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FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
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15 November 2019 |
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FDA approves first therapy to treat patients with rare blood disorder
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08 November 2019 |
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Digital submission of adverse event reports for investigational new drug applications
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29 October 2019 |
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FDA approves new treatment for patients with migraine
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11 October 2019 |
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FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
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08 October 2019 |
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FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
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03 October 2019 |
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FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
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24 September 2019 |
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FDA approves first oral GLP-1 treatment for type 2 diabetes
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20 September 2019 |
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FDA takes first action under new international collaboration with Australia and Canada
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17 September 2019 |
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FDA approves first treatment for patients with rare type of lung disease
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09 September 2019 |
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FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs
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15 August 2019 |
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FDA approves first therapy for rare joint tumor
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02 August 2019 |
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FDA approves first treatment for severe hypoglycemia that can be administered without an injection
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25 July 2019 |
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FDA approves first generics of Lyrica
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22 July 2019 |
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FDA approves new treatment for refractory multiple myeloma
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03 July 2019 |
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FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system
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27 June 2019 |
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FDA seeks public feedback on new drug approval transparency efforts
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26 June 2019 |