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FDA takes new steps to advance digital health, opening docket to solicit feedback on software products
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29 May 2018 |
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FDA approves novel preventive treatment for migraine
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18 May 2018 |
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FDA approves first epoetin alfa biosimilar for the treatment of anemia
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15 May 2018 |
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FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
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11 May 2018 |
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FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
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19 April 2018 |
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FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
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11 April 2018 |
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FDA approves new treatment for certain digestive tract cancers
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26 January 2018 |
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FDA approves first treatment for breast cancer with a certain inherited genetic mutation
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12 January 2018 |
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FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
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22 December 2017 |
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FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
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19 December 2017 |
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FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care
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13 December 2017 |
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FDA launches public education campaign to encourage adult smokers trying to quit cigarettes
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11 December 2017 |
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FDA approves first biosimilar for the treatment of certain breast and stomach cancers
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01 December 2017 |
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FDA approves pill with sensor that digitally tracks if patients have ingested their medication
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14 November 2017 |
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FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
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07 November 2017 |
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FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer
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01 November 2017 |
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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
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20 October 2017 |
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FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
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06 October 2017 |
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FDA awards six grants for natural history studies in rare diseases
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06 October 2017 |
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FDA improves access to reports of adverse drug reactions
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28 September 2017 |