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FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
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08 October 2018 |
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FDA approves first treatment for advanced form of the second most common skin cancer
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28 September 2018 |
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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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24 September 2018 |
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FDA approves new kind of treatment for hairy cell leukemia
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13 September 2018 |
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FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
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10 August 2018 |
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FDA approves treatment for two rare types of non-Hodgkin lymphoma
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08 August 2018 |
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FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
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20 July 2018 |
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FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
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18 July 2018 |
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FDA warns of imposters sending consumers fake warning letters
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13 July 2018 |
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FDA takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage
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06 July 2018 |
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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
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25 June 2018 |
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FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies
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21 June 2018 |
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FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
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05 June 2018 |
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FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
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05 June 2018 |
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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 |