API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
https://www.prnewswire.com/news-releases/gilteritinib-as-maintenance-therapy-demonstrated-benefit-in-subgroups-of-flt3-itd-acute-myeloid-leukemia-patients-301846826.html
https://www.fiercepharma.com/pharma/astellas-xospata-comes-short-again-bid-expand-label
https://www.prnewswire.com/news-releases/astellas-and-bmt-ctn-announce-topline-results-from-phase-3-morpho-trial-of-gilteritinib-301767481.html
https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-gilteritinib-fumarate-tablets-13638.pdf
https://www.globenewswire.com/news-release/2022/08/22/2502156/0/en/Kronos-Bio-Announces-First-Patient-Dosed-in-Phase-1b-2-Clinical-Trial-of-Lanraplenib-in-Combination-with-Gilteritinib-in-Acute-Myeloid-Leukemia.html
https://www.fiercepharma.com/pharma/astellas-aml-drug-xospata-failed-its-trial-but-further-analysis-shows-it-benefited-some
https://www.prnewswire.com/news-releases/astellas-xospata-gilteritinib-meets-overall-survival-endpoint-in-commodore-trial-of-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-with-a-flt3-mutation-301257237.html
https://www.prnewswire.com/news-releases/astellas-xospata-gilteritinib-receives-conditional-approval-by-chinas-national-medical-products-administration-for-relapsed-or-refractory-acute-myeloid-leukemia-with-a-flt3-mutation-301221825.html
https://www.prnewswire.com/news-releases/astellas-to-present-new-data-on-gilteritinib-in-flt3-mutation-positive-acute-myeloid-leukemia-at-the-2020-american-society-of-hematology-annual-meeting-301173212.html
http://www.pharmatimes.com/news/nice_publishes_guidance_on_astellas_xospata_1346937
http://www.pmlive.com/pharma_news/nice_recommends_astellas_xospata_for_nhs_use_1345056
http://www.pharmafile.com/news/553627/gilteritinib-becomes-first-nice-approved-oral-therapy-relapsed-or-refractory-acute-myelo
https://www.fiercepharma.com/pharma/merck-s-keytruda-faces-nice-pushback-as-treatment-for-head-and-neck-cancer
https://finance.yahoo.com/news/health-canada-approves-astellas-xospata-120700729.html
https://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-results-from-astellas-phase-3-admiral-trial-of-xospata-gilteritinib-in-adult-patients-with-flt3-mutation-positive-relapsedrefractory-acute-myeloid-leukemia1-300949374.html
https://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-results-from-astellas-phase-3-admiral-trial-of-xospata-gilteritinib-in-adult-patients-with-flt3-mutation-positive-relapsedrefractory-acute-myeloid-leukemia1-300949374.html
https://www.prnewswire.com/news-releases/european-commission-approves-astellas-xospata-for-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-with-mutations-detected-using-invivoscribes-leukostrat-cdx-flt3-mutation-assay-300947718.html
http://www.pmlive.com/pharma_news/astellas_stays_ahead_of_its_flt3_rivals_with_eu_nod_for_xospata_1314537
http://www.pharmatimes.com/news/xospata_bags_european_commission_approval_1314538
http://www.pmlive.com/pharma_news/astellas_xospata_scores_positive_chmp_recommendation_1302267
http://www.pharmatimes.com/news/xospata_leads_latest_chmp_recommendations_1302120
https://endpts.com/astellas-aml-drug-wins-over-chmp-strengthening-lead-on-daiichi-sankyo/
https://www.raps.org/news-and-articles/news-articles/2019/9/emas-chmp-recommends-three-new-medicines
https://endpts.com/celgenes-aml-drug-clears-late-stage-test/
https://www.fiercebiotech.com/biotech/fda-nixes-daiichi-s-blood-cancer-drug-quizartinib-as-japanese-regulators-wave-it-through
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-addition-survival-data-gilteritinib-label-refractory-aml-flt3-mutation
https://www.fiercebiotech.com/biotech/daiichi-s-xospata-rival-pushed-back-by-fda-as-it-combs-over-new-data
https://www.fiercepharma.com/pharma/astellas-pads-xospata-lead-positive-aml-survival-data
https://www.pharmaceutical-technology.com/news/penn-results-targeted-aml-drug-gilteritinib/
http://www.pharmatimes.com/news/ema_accepts_marketing_authorisation_applications_for_idefirix_and_xospata_1279861
https://endpts.com/fda-stamps-fast-ok-on-astellas-pioneering-flt3-aml-drug-gilteritinib-expanding-on-a-record-year-for-new-approvals/
https://globenewswire.com/news-release/2018/09/27/1577006/0/en/Invivoscribe-Receives-Approval-in-Japan-for-its-LeukoStrat-CDx-FLT3-Mutation-Assay-to-Assess-Acute-Myeloid-Leukemia-AML-Patients-Eligible-for-Treatment-with-Xospata-gilteritinib-fu.html
http://www.pharmatimes.com/news/priority_review_for_astellas_aml_drug_1237552
https://www.prnewswire.com/news-releases/astellas-submits-new-drug-applications-for-approval-of-gilteritinib-for-the-treatment-of-flt3mut-relapsed-or-refractory-acute-myeloid-leukemia-300634947.html