{"schema":"hottub-news/story/v1","story":"st_vh6kljddlfk7232w24zq","title":"Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis","title_en":null,"outlets":4,"brief":null,"page":"https://hottub.news/stories/roches-fenebrutinib-is-the-first-btk-inhibitor-to-receive-u-s-fda-vh6kljddlf","count":4,"items":[{"id":"n_mvb63jwrrqz27d2yjmoa","seq":829241,"kind":"article","title":"F. Hoffmann-La Roche Ltd: Roche's fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis","url":"https://www.finanznachrichten.de/nachrichten-2026-09/69711776-f-hoffmann-la-roche-ltd-roche-s-fenebrutinib-is-the-first-btk-inhibitor-to-receive-u-s-fda-filing-acceptance-in-both-relapsing-and-primary-progress-399.htm","published":"2026-09-30T05:22:42Z","seen":"2026-09-30T05:22:42Z","lang":"en","country":"DE","source":{"id":"finanznachrichten.de","name":"finanznachrichten.de","domain":"finanznachrichten.de","outlet":{"wikidata":"Q1408247","name":"Finanznachrichten.de","type":"website","designations":["website"]}},"via":"gdelt-gkg-english","topics":["economy","politics","health","science"],"authors":["GlobeNewswire (Europe)"],"entities":[{"id":"Q2160232","name":"Roche","type":"org"},{"id":"Q23304817","name":"fenebrutinib","type":"other"},{"id":"Q8277","name":"multiple sclerosis","type":"other"}],"story":"st_vh6kljddlfk7232w24zq","category":"health","category_p":0.5799999833106995,"sentiment":"neutral","tone":-0.2800000011920929,"political":0.10000000149011612},{"id":"n_cx3jeqzei7hdkan4hpfq","seq":832203,"kind":"article","title":"Roche's fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis","url":"https://www.manilatimes.net/2026/09/30/tmt-newswire/globenewswire/roches-fenebrutinib-is-the-first-btk-inhibitor-to-receive-us-fdafiling-acceptance-in-both-relapsing-and-primary-progressive-multiple-sclerosis/2435722","published":"2026-09-30T05:12:00Z","seen":"2026-09-30T05:40:22Z","lang":"en","source":{"id":"manilatimes.net","name":"manilatimes.net","domain":"manilatimes.net","outlet":{"wikidata":"Q1573100","name":"The Manila Times","type":"magazine","country":"PH","designations":["organization","periodical"]}},"via":"gdelt-gkg-english","topics":["economy","health","politics","science"],"entities":[{"id":"Q2160232","name":"Roche","type":"org"},{"id":"Q23304817","name":"fenebrutinib","type":"other"},{"id":"Q423572","name":"Bruton's tyrosine kinase","type":"other"},{"id":"Q8277","name":"multiple sclerosis","type":"other"}],"story":"st_vh6kljddlfk7232w24zq","category":"health","category_p":0.6000000238418579,"sentiment":"positive","tone":-0.17000000178813934,"political":0.11999999731779099},{"id":"n_groe4ykjj7bl3igbuwxa","seq":868834,"kind":"article","title":"Genentech’s Fenebrutinib Is the First BTK Inhibitor to Receive U.S. FDA Filing Acceptance in Both Relapsing and Primary Progressive Multiple Sclerosis","url":"https://www.timesargus.com/news/business/genentech-s-fenebrutinib-is-the-first-btk-inhibitor-to-receive-u-s-fda-filing-acceptance/article_74075de6-ac76-5ff7-8e73-e744f000e7ce.html","summary":"SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 30, 2026--","published":"2026-09-30T05:00:38Z","seen":"2026-09-30T09:33:01Z","lang":"en","country":"US","source":{"id":"kite-timesargus-com-f2ab3d","name":"timesargus.com","domain":"timesargus.com","outlet":{"wikidata":"Q4863287","name":"Barre Montpelier Times Argus","type":"newspaper","country":"US","designations":["newspaper"]}},"via":"kite-timesargus-com-f2ab3d","topics":["vermont"],"authors":["Business Wire"],"entities":[{"id":"Q899140","name":"Genentech","type":"org"},{"id":"Q23304817","name":"fenebrutinib","type":"other"}],"story":"st_vh6kljddlfk7232w24zq","category":"health","category_p":0.4399999976158142,"category2":"science-technology","sentiment":"neutral","tone":0.17000000178813934,"political":0.1599999964237213},{"id":"n_vh6kljddlfk7232w24zq","seq":826959,"kind":"press_release","title":"Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis","url":"https://www.globenewswire.com/news-release/2026/09/30/3371506/0/en/roche-s-fenebrutinib-is-the-first-btk-inhibitor-to-receive-u-s-fda-filing-acceptance-in-both-relapsing-and-primary-progressive-multiple-sclerosis.html","summary":"Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive…","published":"2026-09-30T05:00:00Z","seen":"2026-09-30T05:10:18Z","lang":"en","source":{"id":"globenewswire-all","name":"GlobeNewswire — all","domain":"globenewswire.com","outlet":{"wikidata":"Q5570956","name":"GlobeNewswire","type":"other","country":"US","designations":["business","press release distributor"]}},"via":"globenewswire-all","topics":["business","swx:ro","otc markets:rhhby","swx:rog","ch0012032113","us7711951043","ch0012032048","9015"],"entities":[{"id":"Q2160232","name":"Roche","type":"org"},{"id":"Q23304817","name":"fenebrutinib","type":"other"},{"id":"Q8277","name":"multiple sclerosis","type":"other"}],"mentions":2,"story":"st_vh6kljddlfk7232w24zq","category":"health","category_p":0.5899999737739563,"sentiment":"positive","tone":0.2800000011920929,"political":0.12999999523162842}]}