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American legal mechanism
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section
Breakthrough_therapy
granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can
List of drugs granted breakthrough therapy designation
List_of_drugs_granted_breakthrough_therapy_designation
approval based surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate
Regenerative medicine advanced therapy
Regenerative_medicine_advanced_therapy
Genetic disorder affecting mostly the lungs
breakthrough therapy for cystic fibrosis". FDA. Archived from the original on 23 October 2019. Retrieved 13 November 2019. "CFTR Modulator Therapies"
Cystic_fibrosis
Use of psychedelic drugs as treatment
has granted "breakthrough therapy" status, which expedites the potential approval of promising drug therapies, to psychedelic therapies using psilocybin
Psychedelic_therapy
Psychedelic medicine biotech company
mood, sleep and neuroplasticity. In March 2024, the FDA granted breakthrough therapy designation to MindMed's form of LSD (MM120; now DT120) for the treatment
Definium_Therapeutics
Pharmaceutical compound
adenocarcinoma (PDAC) containing KRAS G12X mutations. It received a breakthrough therapy designation from the US FDA in 2025. Daraxonrasib is an orally active
Daraxonrasib
Chemical compound
the treatment of HDFN. In February 2024, nipocalimab was granted breakthrough therapy designation by the US Food and Drug Administration for the treatment
Nipocalimab
Investigational medication for essential tremor
the U.S. Food and Drug Administration (FDA) granted ulixacaltamide Breakthrough Therapy Designation in December 2025. In February 2026, the company submitted
Ulixacaltamide
American biopharmaceutical startup
for use against a solid tumor. In January 2025, the FDA granted breakthrough therapy designation to Adaptimmune's Letetresgene Autoleucel (lete-cel) for
Adaptimmune
Experimental use of psilocybin to treat anxiety & depression
2018–19, the United States Food and Drug Administration (FDA) granted breakthrough therapy designation to facilitate further research for psilocybin in the
Psilocybin_therapy
Medication
granted the application for datopotamab deruxtecan priority review and breakthrough therapy designations. Efficacy was evaluated in TROPION-Breast02 (NCT05374512)
Datopotamab_deruxtecan
British psychedelic medicine company
on the MADRS depression rating scale. This candidate has received breakthrough therapy status from the U.S. Food and Drug Administration (FDA). It is the
Compass_Pathways
Medical technology
January 2022. "Celladon Receives Breakthrough Therapy Designation From FDA for Mydicar, Novel, First-in-Class Therapy in Development to Treat Heart Failure"
Gene_therapy
Type or designation of pharmaceuticals
the breakthrough therapy designation. On February 3, 2015 New York-based Pfizer's drug Ibrance was approved through the FDA's Breakthrough Therapy designation
Specialty drugs in the United States
Specialty_drugs_in_the_United_States
Movement to decriminalize psilocybin in the United States
October 2018, the Food and Drug Administration granted psilocybin "breakthrough therapy" status for research. The drug was granted this status again in November
Psilocybin decriminalization in the United States
Psilocybin_decriminalization_in_the_United_States
Monoclonal antibody
inhibitors. In October 2018, the FDA expanded approval, under the breakthrough therapy designation, to include all patients with hemophilia A, regardless
Emicizumab
Controlled administration of psychoactive drug MDMA to facilitate psychotherapy efficacy
erythema, and depression. In 2017, a Phase II clinical trial led to a breakthrough therapy designation by the U.S. Food and Drug Administration (FDA). With
MDMA-assisted_psychotherapy
Monoclonal antibody
talquetamab priority review, breakthrough therapy, and orphan drug designations. In the United States, Janssen received breakthrough therapy designation for talquetamab
Talquetamab
Monoclonal antibody
commercialization rights to the drug from Genmab. Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma. It was granted orphan
Daratumumab
Medication
sotatercept, 45 placebo). The FDA granted the application for sotatercept breakthrough therapy designation. In August 2024, sotatercept was authorized for medical
Sotatercept
Medication
the United States Food and Drug Administration (FDA) granted the breakthrough therapy designation to venetoclax for people with CLL or SLL who have relapsed
Venetoclax
Investigational antipsychotic
associated with an improvement in sleep quality. Ulotaront was awarded a Breakthrough Therapy designation due to its increased efficacy and greatly reduced side
Ulotaront
Monoclonal antibody
atezolizumab (Tecentriq). In January 2021, tiragolumab received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for
Tiragolumab
Medical condition
Food and Drug Administration (FDA) granted breakthrough therapy designation for psilocybin-assisted therapy for treatment-resistant depression. A systematic
Treatment-resistant depression
Treatment-resistant_depression
Commercial pharmaceutical company
December 2016 after the Phase IIa trial was done, TNX-102 was granted Breakthrough Therapy designation by the FDA in December 2017 which was rescinded in January
Tonix_Pharmaceuticals
Chemical compound
the application for resmetirom accelerated approval, along with breakthrough therapy, fast track, and priority review designations. The FDA granted the
Resmetirom
Chemical compound
Administration granted the application for aficamten orphan drug and breakthrough therapy designations. In December 2025, the Committee for Medicinal Products
Aficamten
MRNA-based cancer vaccine
Vaccine, in Combination With KEYTRUDA® (pembrolizumab), was Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients With High-Risk
Intismeran_autogene
Anti-breast cancer medication
CDK inhibitor selective for CDK4 and CDK6. It was designated as a breakthrough therapy for breast cancer by the US Food and Drug Administration (FDA) in
Abemaciclib
Pharmaceutical drug
it has been designated by the Food and Drug Administration as a breakthrough therapy for patients with locally advanced or metastatic NSCLCs with an EGFR
Sunvozertinib
Drug used to treat allergic diseases
with moderate-to-severe eczema. The FDA granted the application breakthrough therapy designation. In a 2020 cost-effectiveness study dupilumab was inferior
Dupilumab
American pharmaceutical company
and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted Breakthrough Therapy designation from FDA". Reuters. November 16, 2017. "Bristol
Bluebird_bio
Experimental anti-cancer treatment
cytotoxic DNA topoisomerase I inhibitor. In September, 2025, it received breakthrough therapy designation from the FDA for adult patients with platinum-resistant
Raludotatug_deruxtecan
US FDA designation for investigational drugs
the others are priority review, breakthrough therapy, accelerated approval and regenerative medicine advanced therapy. Fast track was introduced by the
Fast_track_(FDA)
Artificial stimulation of the immune system to treat cancer
member 7 (SLAMF7) through two mechanisms. In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple
Cancer_immunotherapy
Autoimmune disease
13 August 2014. "Novartis' investigational therapy for Sjögren's disease receives FDA Breakthrough Therapy designation". Sjögren’s Foundation. 2026-01-16
Sjögren's_disease
Chemical compound
US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. In April 2026, the FDA granted priority review
Pritelivir
Combination cystic fibrosis medication
granted the application priority review, in addition to fast track, breakthrough therapy, and orphan drug designations. The drug's manufacturer Vertex Pharmaceuticals
Elexacaftor/tezacaftor/ivacaftor
Elexacaftor/tezacaftor/ivacaftor
Antibody-drug conjugate
Immunomedics announced that sacituzumab govitecan had received an FDA breakthrough therapy designation (a classification designed to expedite the development
Sacituzumab_govitecan
Medical condition
long-standing and severe disease. In March 2020, the US FDA granted breakthrough therapy designation to baricitinib for the systematic treatment of alopecia
Alopecia_areata
Monoclonal antibody medication
wheat, cashew, hazelnut, or walnut. The FDA granted the application breakthrough therapy designation. In March 2024, the Committee for Medicinal Products
Omalizumab
Piece of American regulatory legislation
devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program
Food and Drug Administration Safety and Innovation Act
Food_and_Drug_Administration_Safety_and_Innovation_Act
Pharmaceutical compound
developed by Nektar Therapeutics. In August 2019 the FDA granted breakthrough therapy designation to bempegaldesleukin in combination with nivolumab for
Bempegaldesleukin
American non-profit medical research organization
year, this candidate received Food and Drug Administration (FDA) "breakthrough therapy" designation. This clinical trial has since been completed and its
Usona_Institute
Form of integrative psychotherapy
Schema therapy is a form of integrative psychotherapy developed by Jeffrey E. Young for use in the treatment of personality disorders and other chronic
Schema_therapy
Chemical compound
or plans to conduct these studies. Erdafitinib was also granted breakthrough therapy designation. The FDA granted the approval of Balversa to Janssen
Erdafitinib
Anti-CD20 monoclonal antibody
February 2016, the US Food and Drug Administration (FDA) granted breakthrough therapy designation for primary progressive multiple sclerosis. In March
Ocrelizumab
Monoclonal antibody
the United States in August 2024. The FDA granted the application breakthrough therapy designation. In December 2024, the Committee for Medicinal Products
Nemolizumab
Chemical compound
August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US
Bimagrumab
Antiretroviral medication
the application for lenacapavir priority review, fast track, and breakthrough therapy designations. Lenacapavir was approved for medical use in the United
Lenacapavir
Pharmaceutical drug
furthered the drug's clinical trials. In July 2014, the FDA granted breakthrough therapy status to blinatumomab for the treatment of acute lymphoblastic leukemia
Blinatumomab
Gene therapy
Zynteglo, is a gene therapy for the treatment for beta thalassemia. It was developed by Bluebird Bio and was given breakthrough therapy designation by the
Betibeglogene_autotemcel
Anti-diabetic and anti-obesity medication
application for tirzepatide (Zepbound) fast track, priority review, and breakthrough therapy designations for the treatment of moderate to severe obstructive
Tirzepatide
Pharmaceutical drug
advanced metastatic urothelial bladder (Study 1108) has led to FDA breakthrough therapy designation. Early results of a phase I trial combining durvalumab
Durvalumab
Therapeutic interventions for post-traumatic stress disorder
In 2018, the US Food and Drug and Drug Administration granted "Breakthrough Therapy" designation for MDMA-assisted psychotherapy trials. There is weak
Management of post-traumatic stress disorder
Management_of_post-traumatic_stress_disorder
Monoclonal antibody against amyloid beta
granted the application for donanemab fast track, priority review, and breakthrough therapy designations. In October 2024, donanemab was approved for medical
Donanemab
Type 1 diabetes charity
technologies, and therapies are discovered. Breakthrough T1D prioritizes four strategic research areas; autoimmune therapies, cell therapies, prevention of
Breakthrough_T1D
Mental disorder associated with trauma
specifically authorized psychiatrists. Although once considering MDMA as a "breakthrough therapy", the FDA rejected it for treating PTSD in 2024, citing trial design
Post-traumatic stress disorder
Post-traumatic_stress_disorder
Gene therapy medication for hemophilia A
the gene therapy to be effective and safe. The FDA granted the application for valoctocogene roxaparvovec orphan drug, breakthrough therapy, regenerative
Valoctocogene_roxaparvovec
Swiss multinational healthcare company
Holding. 3 February 2025. Retrieved 3 February 2025. "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19
Roche
Non-opioid analgesic drug
novel mechanism, the FDA granted priority review, fast track, and breakthrough therapy designations to the application for suzetrigine. In January 2025
Suzetrigine
Indian multinational pharmaceutical company
Standard India. Retrieved 17 March 2022. "Zydus launches SoviHep - the breakthrough therapy for Hepatitis C in alliance with Gilead Sciences". The Hindu Business
Zydus_Lifesciences
France-based pharmaceutical group
2014. Parsons, Lucy (2021-06-21). "Novartis' radioligand therapy granted US Breakthrough Therapy Designation". PharmaTimes Online. Retrieved 2021-07-10
Advanced Accelerator Applications
Advanced_Accelerator_Applications
Process of bringing a new pharmaceutical drug to the market
Path Initiative" to enhance innovation of drug development, and the Breakthrough Therapy designation to expedite development and regulatory review of candidate
Drug_development
Chemical compound
treatment of rheumatoid arthritis. In March 2020, the US FDA granted breakthrough therapy designation to baricitinib for the treatment of alopecia areata and
Baricitinib
Medication
Administration granted the application for zongertinib priority review, breakthrough therapy, and fast track designations. Zongertinib was approved for medical
Zongertinib
Term for a groundbreaking pharmaceutical drug
many first-in-class medications qualify as breakthrough therapies, Regenerative Medicine Advanced Therapies and/or orphan drugs, first-in-class status
First-in-class_medication
Pharmaceutical drug used in cancer treatment
melanoma and lung cancer. In 2013, Merck quietly applied for and won a breakthrough therapy designation for the drug. This regulatory pathway was new at the
Pembrolizumab
Medication
treatment for chronic lymphocytic leukemia, and was the first drug with breakthrough therapy designation to gain approval. In October 2014, NICE announced that
Obinutuzumab
Gene therapy medication
is a gene therapy used to treat cerebral adrenoleukodystrophy (CALD). It was developed by Bluebird Bio and was given breakthrough therapy designation
Elivaldogene_autotemcel
Canadian pharmaceutical company
with onset within 15 minutes of dosing. HLP003 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the adjunctive
Helus_Pharma
Chemical compound, used as a medication to treat lung cancer
T790M form of the EGFR receptor. Osimertinib was designated as a breakthrough therapy in April 2014, based on phase I trial results, and the drug was provisionally
Osimertinib
Chemical compound
acquired Naurex in July 2015) announced that rapastinel had received Breakthrough Therapy designation from the U.S. FDA for adjunctive treatment of major depressive
Rapastinel
Nonspecific long-lasting anxiety
2022.106204. ISSN 1096-1186. PMID 35378276. "MindMed Receives FDA Breakthrough Therapy Designation and Announces Positive 12-Week Durability Data From Phase
Generalized_anxiety_disorder
American pharmaceutical company
to an open-label Phase 2 trial. In April 2013 Scioderm received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for
Scioderm
Monoclonal antibody
Administration (FDA) granted orphan drug designations in 2010 and 2020, and breakthrough therapy designation in 2016, on the basis of preliminary data from the phase
Emapalumab
Medication
and the European Union in 2024. The FDA granted the application breakthrough therapy designation. In February 2024, the Committee for Medicinal Products
Danicopan
Chemical compound
the United States in August 2024. The FDA granted the application breakthrough therapy designation. In December 2024, the Committee for Medicinal Products
Seladelpar
American multinational pharmaceutical company
Drug Administration (FDA) approved Pembrolizumab (MK-3475) as a breakthrough therapy for melanoma treatment. In clinical trials, pembrolizumab provided
Merck_&_Co.
American biotechnology company
surface of B-cell lymphomas and leukemias. It garnered a US FDA Breakthrough Therapy Designation (Dec 2015) for the treatment of patients with refractory
Kite_Pharma
Monoclonal antibody
trial. Through this trial, lanadelumab was given priority review, breakthrough therapy, and orphan drug designations by the Food and Drug Administration
Lanadelumab
Chemical compound
Administration (FDA) granted the application for revumenib priority review, breakthrough therapy, and orphan drug designations. Efficacy was evaluated in a single-arm
Revumenib
Psychoactive drug, often called ecstasy
United States, the Food and Drug Administration (FDA) has given MDMA breakthrough therapy status (though there are no current clinical indications in the US)
MDMA
Type of corticosteroid medication
the European Union in July 2022. The FDA granted the application breakthrough therapy designation. Budesonide was recommended in April 2021 by the UK's
Budesonide
Monoclonal antibody
was planned, and 4 were terminated. It was designated as an FDA breakthrough therapy for Sjogren's disease in January 2026. World Health Organization
Ianalumab
Italian pharmaceutical company
neurotrophic keratitis. Cenegermin received fast track status as well as breakthrough therapy designation and Priority Review from the Food and Drug Administration
Dompé_Farmaceutici
Anti-cancer medication
granted the application for vorasidenib priority review, fast track, breakthrough therapy, and orphan drug designations. In July 2025, the Committee for Medicinal
Vorasidenib
Monoclonal antibody
Administration (FDA) granted the application for tarlatamab priority review, breakthrough therapy, and orphan drug designations. Efficacy was evaluated in DeLLphi-304
Tarlatamab
Medication
designation for the idiopathic pulmonary fibrosis indication and breakthrough therapy designation for the progressive pulmonary fibrosis indication. In
Nerandomilast
American doctor
that obtained Breakthrough Therapy designation and FDA approval for Fidanacogene elaparvovec to treat Hemophilia B and Breakthrough Therapy designation
Katherine_A._High
Monoclonal antibody
placebo. In 2021, the US Food and Drug Administration ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous
Ligelizumab
Cystic fibrosis medication
5863/1551-6776-25.3.192. PMC 7134581. PMID 32265602. "FDA approves new breakthrough therapy for cystic fibrosis". U.S. Food and Drug Administration (FDA) (Press
Elexacaftor
Pharmaceutical drug
member 7 (SLAMF7) through two mechanisms. In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple
Elotuzumab
Irish tax-registered pharmaceutical corporation
Pharmaceuticals for $1.5 billion. As a result, Jazz obtained the rights to breakthrough therapy Vyxeos (liposomal daunorubicin and cytarabine) for treatment of acute
Jazz_Pharmaceuticals
Serotonergic psychedelic
deuterated phenethylamine HLP005 (CYB005). In 2024, HLP003 received a breakthrough therapy designation from the U.S. FDA and was in phase 3 clinical trials
HLP003
American politician (born 1963)
Breakthrough Therapies Act to allow Schedule I drugs such as psilocybin and MDMA to be rescheduled when they are designated as breakthrough therapies
Rand_Paul
American biopharmaceutical company
data from MD Anderson's ongoing Phase 2 study, FDA did not grant Breakthrough Therapy Designation (BTD) to Poziotinib for the treatment of patients with
Spectrum_Pharmaceuticals
Psychedelic drug
Drug Administration designated LSD (code name MM120 or DT120) as a breakthrough therapy for generalized anxiety disorder. As of 2017, about 10% of people
LSD
Medication
Administration (FDA) granted the application for tovorafenib priority review, breakthrough therapy, and orphan drug designations. Tovorafenib was approved for medical
Tovorafenib
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
Male
Spanish
Spanish form of Middle Latin Venceslaus, VENCESLÃS means "more glory."Â
Surname or Lastname
English (of Norman origin)
English (of Norman origin) : habitational name for someone from Plasnes in Eure.
Girl/Female
Assamese, Bengali, Gujarati, Hindu, Indian, Kannada, Malayalam, Marathi, Sindhi, Tamil, Telugu
Sound; Beautiful Girl
Boy/Male
British, English, French, Hebrew
To Forget; The Elder Son of Joseph in the Old Testament; Forgetful; Causing to Forget
Surname or Lastname
English
English : variant spelling of Wilson.
Boy/Male
Tamil
Sabari Gireesh | ஸாபரீ கீரீஷÂ
Lord of Sabari hill, Lord Ayyappa
Girl/Female
Indian
Clever
Female
English
Elaborated form of English Andrea, ANDRIANA means "man; warrior."
Girl/Female
Hindu
Belonging of Lord Shiv, Whose owner is Lord Shiv, Lord Shiv in female form. Goddess Parvati
Girl/Female
Biblical
Mourning of thorns.
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
BREAKTHROUGH THERAPY
n.
Therapeutics.