PDUFA https://www.bioworld.com/rss en-us LHON updates: Gene therapy progress; idebenone receives US CRL http://www.bioworld.com/articles/730074 Thu, 02 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730074-lhon-updates-gene-therapy-progress-idebenone-receives-us-crl Eye and DNA illustration Workload reductions figure into FDA’s FY2026 user fees http://www.bioworld.com/articles/722783 Mon, 04 Aug 2025 11:00:00 -0400 https://www.bioworld.com/articles/722783-workload-reductions-figure-into-fdas-fy2026-user-fees Blue dollar sign on white background Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study http://www.bioworld.com/articles/722456 Tue, 22 Jul 2025 11:00:00 -0400 https://www.bioworld.com/articles/722456-adcom-agrees-with-fda-otsukas-ptsd-treatment-needs-more-study Rexulti Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study http://www.bioworld.com/articles/722265 Fri, 18 Jul 2025 11:00:00 -0400 https://www.bioworld.com/articles/722265-adcom-agrees-with-fda-otsukas-ptsd-treatment-needs-more-study Rexulti FDA wants more data for Otsuka’s sNDA in PTSD http://www.bioworld.com/articles/722161 Wed, 16 Jul 2025 11:00:00 -0400 https://www.bioworld.com/articles/722161-fda-wants-more-data-for-otsukas-snda-in-ptsd Woman in military clothing talking with psychologist Split adcom vote not what Urogen envisioned http://www.bioworld.com/articles/720349 Wed, 21 May 2025 16:00:00 -0400 https://www.bioworld.com/articles/720349-split-adcom-vote-not-what-urogen-envisioned Street a bit uneasy ahead of Urogen adcom http://www.bioworld.com/articles/720322 Mon, 19 May 2025 11:00:00 -0400 https://www.bioworld.com/articles/720322-street-a-bit-uneasy-ahead-of-urogen-adcom PDUFA date miss another disappointing delay for Barth drug http://www.bioworld.com/articles/719679 Tue, 29 Apr 2025 11:00:00 -0400 https://www.bioworld.com/articles/719679-pdufa-date-miss-another-disappointing-delay-for-barth-drug US FDA deals second blow to Hengrui-HLB’s liver cancer drug combo http://www.bioworld.com/articles/718608 Tue, 25 Mar 2025 11:00:00 -0400 https://www.bioworld.com/articles/718608-us-fda-deals-second-blow-to-hengrui-hlbs-liver-cancer-drug-combo US FDA deals second blow to Hengrui-HLB’s liver cancer drug combo http://www.bioworld.com/articles/718404 Fri, 21 Mar 2025 11:00:00 -0400 https://www.bioworld.com/articles/718404-us-fda-deals-second-blow-to-hengrui-hlbs-liver-cancer-drug-combo Regeneron starts the week with two CRLs http://www.bioworld.com/articles/706988 Mon, 25 Mar 2024 12:00:00 -0400 https://www.bioworld.com/articles/706988-regeneron-starts-the-week-with-two-crls Magnifying glass, FDA concept image FDA accepts Venatorx NDA for cUTI antibiotic; PDUFA early 2024 http://www.bioworld.com/articles/699931 Wed, 16 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/699931-fda-accepts-venatorx-nda-for-cuti-antibiotic-pdufa-early-2024 Illustration of infected kidneys, ureter and bladder PDUFA VII keeping pace with the present, prepping for the future http://www.bioworld.com/articles/511849 Tue, 28 Sep 2021 12:00:00 -0400 https://www.bioworld.com/articles/511849-pdufa-vii-keeping-pace-with-the-present-prepping-for-the-future Provention’s CRL prevents completion of its July 2 PDUFA http://www.bioworld.com/articles/509015 Tue, 06 Jul 2021 12:00:00 -0400 https://www.bioworld.com/articles/509015-proventions-crl-prevents-completion-of-its-july-2-pdufa Glucose monitoring Athenex specs checked as Oraxol awaits PDUFA date http://www.bioworld.com/articles/503770 Thu, 18 Feb 2021 12:00:00 -0500 https://www.bioworld.com/articles/503770-athenex-specs-checked-as-oraxol-awaits-pdufa-date Oral medication Still on deck for FDA action, developers continue to wait beyond PDUFAs http://www.bioworld.com/articles/503127 Tue, 02 Feb 2021 17:32:00 -0500 https://www.bioworld.com/articles/503127-still-on-deck-for-fda-action-developers-continue-to-wait-beyond-pdufas Calendar pages Still on deck for FDA action, developers continue to wait beyond PDUFAs http://www.bioworld.com/articles/503056 Tue, 02 Feb 2021 10:00:00 -0500 https://www.bioworld.com/articles/503056-still-on-deck-for-fda-action-developers-continue-to-wait-beyond-pdufas Calendar pages Tsunami of change to challenge PDUFA VII http://www.bioworld.com/articles/496202 Thu, 23 Jul 2020 12:00:00 -0400 https://www.bioworld.com/articles/496202-tsunami-of-change-to-challenge-pdufa-vii Meeting illustration PDUFA, BsUFA delays could be in the offing http://www.bioworld.com/articles/435376 Wed, 27 May 2020 12:00:00 -0400 https://www.bioworld.com/articles/435376-pdufa-bsufa-delays-could-be-in-the-offing