BEGIN:VCALENDAR VERSION:2.0 PRODID:-//Julien Willard//Catalyst Calendar//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:Biotech catalysts: fda actions X-WR-CALDESC:Regulatory actions the FDA has already taken\, plus advisory c ommittee meetings it has formally noticed in the Federal Register. URL:https://julienwillard.com/calendar/fda X-PUBLISHED-TTL:PT24H REFRESH-INTERVAL;VALUE=DURATION:PT24H BEGIN:VEVENT UID:008c5d9e725cba702e4c9f32cfc42da1 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260714 DTEND;VALUE=DATE:20260715 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Revtorpyk (gedatolisib): FDA approval DESCRIPTION:FDA approved Revtorpyk (gedatolisib) on 14 July 2026.\n\nSource : novel-approvals 2026:Revtorpyk\nhttps://www.fda.gov/drugs/novel-drug-app rovals-fda/novel-drug-approvals-2026 URL:https://julienwillard.com/calendar/fda#e-50cec356-20d2-40ed-a877-cc9970 31a24a END:VEVENT BEGIN:VEVENT UID:6167471e536e011fc8b98359d96655e9 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260715 DTEND;VALUE=DATE:20260716 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Lipfendra (enlicitide decanoate): FDA approval DESCRIPTION:FDA approved Lipfendra (enlicitide decanoate) on 15 July 2026 t o reduce low-density lipoprotein cholesterol.\n\nSource: novel-approvals 2 026:Lipfendra\nhttps://www.fda.gov/drugs/novel-drug-approvals-fda/novel-dr ug-approvals-2026 URL:https://julienwillard.com/calendar/fda#e-da9dd90e-22b8-49b6-b5e7-4f2e35 940c21 END:VEVENT BEGIN:VEVENT UID:115c14de6dc91ee8896794ac1d04af03 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260717 DTEND;VALUE=DATE:20260718 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Lipfendra (enlicitide): FDA approval DESCRIPTION:FDA approved Lipfendra (enlicitide) on 17 July 2026.\n\nSource: fda-press http://www.fda.gov/news-events/press-announcements/fda-approves -first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol\ nhttp://www.fda.gov/news-events/press-announcements/fda-approves-first-ora l-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol URL:https://julienwillard.com/calendar/fda#e-eeab8d2d-afcf-4ada-be62-546024 ae013e END:VEVENT BEGIN:VEVENT UID:db3ec5616fd83627ccf330dbfeae2946 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260722 DTEND;VALUE=DATE:20260723 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Jideytro (zidesamtinib): FDA approval DESCRIPTION:FDA approved Jideytro (zidesamtinib) on 22 July 2026.\n\nSource : novel-approvals 2026:Jideytro\nhttps://www.fda.gov/drugs/novel-drug-appr ovals-fda/novel-drug-approvals-2026 URL:https://julienwillard.com/calendar/fda#e-a5907111-5575-4d6f-a658-0e8cb6 1d0f52 END:VEVENT BEGIN:VEVENT UID:483ee4c28aa2ccf5e755213346f7589b DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260724 DTEND;VALUE=DATE:20260725 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Lytenava (bevacizumab-vikg): FDA approval DESCRIPTION:FDA approved Lytenava (bevacizumab-vikg) on 24 July 2026 to tre at patients with neovascular (wet) age-related macular degeneration.\n\nSo urce: novel-approvals 2026:Lytenava\nhttps://www.fda.gov/drugs/novel-drug- approvals-fda/novel-drug-approvals-2026 URL:https://julienwillard.com/calendar/fda#e-b9ce71ea-8e34-43de-a126-214844 b5e9be END:VEVENT BEGIN:VEVENT UID:c330d139080c15c9af5b2a0ba1d64b76 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260724 DTEND;VALUE=DATE:20260725 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Simtriyo (centanafadine): FDA approval DESCRIPTION:FDA approved Simtriyo (centanafadine) on 24 July 2026 to treat attention-deficit hyperactivity disorder.\n\nSource: novel-approvals 2026: Simtriyo\nhttps://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-ap provals-2026 URL:https://julienwillard.com/calendar/fda#e-53d54e75-86aa-4da5-bd6a-4b3386 7fa2f5 END:VEVENT BEGIN:VEVENT UID:2fce106196d23b4086c6248fb8e96151 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260729 DTEND;VALUE=DATE:20260730 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Capricor\, Inc. BLA 125842: FDA advisory committee DESCRIPTION:An FDA advisory committee meets on 29 July 2026 to review BLA 1 25842 from Capricor.\n\nSource: federal-register 2026-13096\nhttps://www.f ederalregister.gov/documents/2026/06/29/2026-13096/cellular-tissue-and-gen e-therapies-advisory-committee-notice-of-meeting-establishment-of-a-public URL:https://julienwillard.com/calendar/fda#e-1a29df3c-5dee-4eb5-8c2e-474d8a f6f941 END:VEVENT BEGIN:VEVENT UID:c7e5ab1946b7c63c3e6426ac6600051d DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260730 DTEND;VALUE=DATE:20260731 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Replimune\, Inc. BLA 125827: FDA advisory committee DESCRIPTION:An FDA advisory committee meets on 30 July 2026 to review BLA 1 25827 from Replimune.\n\nSource: federal-register 2026-13810\nhttps://www. federalregister.gov/documents/2026/07/08/2026-13810/cellular-tissue-and-ge ne-therapies-advisory-committee-notice-of-meeting-establishment-of-a-publi c URL:https://julienwillard.com/calendar/fda#e-52de27db-fff8-46d3-b979-710ddd c68d6f END:VEVENT BEGIN:VEVENT UID:e5bc8047f3a5826cfb3de0e1ea2cd723 DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260805 DTEND;VALUE=DATE:20260806 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Orzeyful (oveporexton): FDA approval DESCRIPTION:FDA approved Orzeyful (oveporexton) on 5 August 2026 to treat n arcolepsy type 1.\n\nSource: novel-approvals 2026:Orzeyful\nhttps://www.fd a.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026 URL:https://julienwillard.com/calendar/fda#e-c9ad4dcd-6920-4c83-892c-deac73 484718 END:VEVENT BEGIN:VEVENT UID:dc83bb6bc08d0ecab4d50400317573fa DTSTAMP:20260812T042022Z DTSTART;VALUE=DATE:20260806 DTEND;VALUE=DATE:20260807 SEQUENCE:0 STATUS:CONFIRMED TRANSP:TRANSPARENT SUMMARY:Tudriqev (vusolimogene oderparepvec-wtpg): FDA accelerated approval DESCRIPTION:FDA granted accelerated approval to Tudriqev (vusolimogene oder parepvec-wtpg) on 6 August 2026.\n\nSource: fda-press http://www.fda.gov/n ews-events/press-announcements/fda-approves-new-engineered-viral-immunothe rapy-patients-treatment-resistant-advanced-melanoma\nhttp://www.fda.gov/ne ws-events/press-announcements/fda-approves-new-engineered-viral-immunother apy-patients-treatment-resistant-advanced-melanoma URL:https://julienwillard.com/calendar/fda#e-b785043f-f6a6-47a4-90f7-494937 e9a70e END:VEVENT END:VCALENDAR