https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-novel-egfr-inhibitor-in-glioblastoma
FDA Grants Fast Track Designation to Novel EGFR Inhibitor in Glioblastoma | CancerNetwork
Oct 6, 2026 - ERAS-801, which now has FDA fast track designation for glioblastoma with EGFR alterations, is currently under investigation as a monotherapy in the phase 1...
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https://www.cellectar.com/investors/news-events/press-releases/detail/206/cellectar-receives-fda-fast-track-designation-for-clr-131-in-relapsed-or-refractory-multiple-myeloma
Cellectar Receives FDA Fast Track Designation for CLR 131 in Relapsed or Refractory Multiple...
Designation could accelerate CLR 131 development and underscores the need for new treatments FLORHAM PARK, N.J., May 13, 2019 (GLOBE NEWSWIRE) --…...
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https://www.onclive.com/view/fda-grants-fast-track-designation-to-emactuzumab-for-unresectable-tgct
FDA Grants Fast Track Designation to Emactuzumab for Unresectable TGCT | OncLive
Oct 5, 2026 - The FDA granted fast track designation to emactuzumab for unresectable tenosynovial giant cell tumor.
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https://www.tokyopoliticalwire.com/article/944240434-quoin-pharmaceuticals-announces-fda-fast-track-designation-for-qrx003-for-the-treatment-of-peeling-skin-syndrome
Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling...
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https://www.mdtechcouncil.com/membership/news/fast-track-designation-for-rockvilles-ict/
Fast Track Designation for Rockville’s ICT
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https://industrytimesnewyork.com/article/872256098-incannex-granted-fda-fast-track-designation-for-ihl-42x-in-obstructive-sleep-apnea-osa
Incannex Granted FDA Fast Track Designation for IHL-42X in Obstructive Sleep Apnea (OSA) | Industry...
Industry Times of New York is an online news publication focusing on industries in the New York: The best news from New York on industries and services
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https://www.vermonttechscene.com/article/871861554-sangamo-therapeutics-receives-u-s-fda-fast-track-designation-for-st-503-for-the-treatment-of-small-fiber-neuropathy
Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small...
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https://trethera.com/fda-fast-track-tre-515-kras-g12c-nsclc/
FDA Grants Fast Track Designation for TRE-515 in Combination with KRAS G12C Inhibitors for the...
Oct 1, 2026 - Second FDA Fast Track designation expands oncology opportunity and supports expedited development across multiple cancer indications
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https://www.nuaxia.com/es/post/fda-grants-fast-track-designation-to-phanes-spevatamig-for-first-line-metastatic-pancreatic-cancer-4
FDA grants Fast Track designation to Phanes’ spevatamig for first-line metastatic pancreatic cancer
Aug 19, 2026 - The designation broadens regulatory support for the CLDN18.2 × CD47 bispecific antibody as Phanes advances its chemotherapy combination through Phase II...
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https://www.assyro.com/glossary/fast-track
Fast Track Designation (Fast Track) - Definition | Assyro AI
Fast Track Designation is an FDA status, granted on sponsor request, that expedites development and review of a drug for a serious or life-threatening
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https://technologyweekliechtenstein.com/article/904290354-climb-bio-announces-fda-fast-track-designation-for-budoprutug-for-the-treatment-of-primary-membranous-nephropathy
Climb Bio Announces FDA Fast Track Designation for Budoprutug for the Treatment of Primary...
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https://vanuatuhealthtimes.com/article/889323951-oncolytics-biotech-receives-fda-fast-track-designation-for-pelareorep-in-2l-kras-mutant-mss-metastatic-colorectal-cancer
Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS...
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https://www.aravax.com.au/aravax-awarded-fda-fast-track-designation-for-pvx108-a-next-generation-immunotherapy-for-the-treatment-of-peanut-allergy/
Aravax Awarded FDA Fast Track Designation for PVX108, a Next-Generation Immunotherapy for the...
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https://vanuatutechnologyupdate.com/article/904299713-nextcure-receives-fast-track-designation-for-sim0505-cdh6-adc-in-ovarian-cancer
NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer | Vanuatu...
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https://oklahomahealthcarewire.com/article/871861554-sangamo-therapeutics-receives-u-s-fda-fast-track-designation-for-st-503-for-the-treatment-of-small-fiber-neuropathy
Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small...
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https://www.cgtlive.com/view/sanofi-dm1-gene-therapy-sar446268-snags-fast-track-designation
Sanofi's DM1 Gene Therapy SAR446268 Snags Fast Track Designation | CGTlive®
Oct 6, 2026 - SAR446268 has previously received orphan drug designations from the FDA and European Medicines Agency.
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https://lasvegasalert.com/quoin-pharmaceuticals-announces-fda-fast-track-designation-for-qrx003-for-the-treatment-of-peeling-skin-syndrome/
Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling...
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https://menafn.com/1110951679/Nextcure-Receives-Fast-Track-Designation-For-SIM0505-CDH6-ADC-In-Ovarian-Cancer
Nextcure Receives Fast Track Designation For SIM0505 (CDH6 ADC) In Ovarian Cancer
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https://www.chinaindustrytimes.com/article/946060191-beyondspring-announces-fda-fast-track-designation-for-plinabulin-in-post-ici-non-squamous-nsclc-and-strategic-transaction-to-advance-global-phase-3
BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and...
China Industry Times is an online news publication focusing on industries in the China: Get your industries and services news from China
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https://www.biospace.com/tracon-pharmaceuticals-announces-fast-track-designation-by-the-fda-for-envafolimab-for-the-treatment-of-the-soft-tissue-sarcoma-subtypes-of-ups-and-mfs
TRACON Pharmaceuticals Announces Fast Track Designation by the FDA for Envafolimab for the...
Sep 14, 2022 - TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the...
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https://bio-research.ai/fda-grants-fast-track-designation-for-anti-cd36-monoclonal-antibody-in-hepatocellular-carcinoma/
FDA grants Fast Track designation for anti-CD36 monoclonal antibody in hepatocellular carcinoma
The FDA granted Fast Track designation for PLT012, an anti-CD36 monoclonal antibody for treating hepatocellular carcinoma (HCC) and other solid tumors. PLT012...
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https://www.onclive.com/view/fda-awards-fast-track-designation-to-ct-0525-for-her2-overexpressing-solid-tumors
FDA Awards Fast Track Designation to CT-0525 for HER2-Overexpressing Solid Tumors | OncLive
Oct 6, 2026 - The FDA has granted fast track designation to CT-0525 for the treatment of patients with HER2-overexpressing solid tumors.
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https://www.insidechina.com/article/946060191-beyondspring-announces-fda-fast-track-designation-for-plinabulin-in-post-ici-non-squamous-nsclc-and-strategic-transaction-to-advance-global-phase-3
BeyondSpring Announces FDA Fast Track Designation for Plinabulin in Post-ICI Non-Squamous NSCLC and...
Inside China is an online news publication focusing on the China
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https://www.bracco.com/en-no/article/bracco-imaging-receives-fda-fast-track-designation-br55
Bracco Imaging Receives FDA Fast Track Designation for BR55 | Bracco
Bracco Imaging announced today that the U.S. FDA has granted Fast Track designation for the development of BR55 (perfluorobutane/nitrogen lipopeptide-coated...
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https://marengotx.com/marengos-first-in-class-invikafusp-alfa-star0602-receives-u-s-fda-fast-track-designation-for-treatment-of-unresectable-locally-advanced-or-metastatic-colorectal-cancers-with-high-tumor-m/
Marengo’s First-in-Class Invikafusp Alfa (STAR0602) Receives U.S. FDA Fast Track Designation for...
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https://medicaex.com/prnewswire/teikoku-pharma-granted-fda-fast-track-designation-for-tpu-006-a-novel-4-day-dexmedetomidine-transdermal-system-for-post-operative-pain-management/
Teikoku Pharma granted FDA Fast Track Designation for TPU-006, a Novel 4-day Dexmedetomidine...
Jun 29, 2023 - SAN JOSE, June 21, 2023 /PRNewswire/ -- Teikoku Pharma USA, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA)...
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https://www.ophthalmologymanagement.com/news/2025/investigational-drug-for-sjogrens-disease-granted-fast-track-designation-from-fda/
Investigational Drug for Sjogrens Disease Granted Fast Track Designation From FDA | Ophthalmology...
Mar 26, 2025 - Conexiant Vision: Delivering trusted clinical content, deep audience engagement, and educational resources for eye care professionals. Discover more through...
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https://www.cgtlive.com/view/sardocor-heart-failure-gene-therapy-srd-001-garners-fast-track-designation-first-patients-dosed
Sardocor’s Heart Failure Gene Therapy SRD-001 Garners Fast Track Designation as First Patients Are...
Oct 7, 2026 - The first 3 participants in the MUSIC-HFpEF trial have now been dosed with the AAV vector-based gene therapy.
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https://www.healthwirecaboverde.com/article/889323951-oncolytics-biotech-receives-fda-fast-track-designation-for-pelareorep-in-2l-kras-mutant-mss-metastatic-colorectal-cancer
Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS...
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https://www.biontech.com/au/en/home/mediaroom/news/press-releases/2024/06/biontech-and-dualitybio-receive-fda-fast-track-designation.html
BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate...
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https://zoomerzest.com/quoin-pharmaceuticals-announces-fda-fast-track-designation-for-qrx003-for-the-treatment-of-peeling-skin-syndrome/
Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling...
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