List of drugs granted breakthrough therapy designation

Short description: none

Below is a list of drugs granted breakthrough therapy designation (BTD) by the Food and Drug Administration (FDA).

Drugs may be listed more than once as BTD can be awarded for multiple indications.

## Contents

* 1 2020
* 2 2019
* 3 2018
* 4 2017
* 5 2016
* 6 2015
* 7 2014
* 8 2013
* 9 References

## 2020

Drug | Manufacturer | Indication

|
|

Avapritinib | Blueprint Medicines Corp | metastatic gastrointestinal stromal tumor
Tepezza | Horizon Therapeutics | thyroid eye disease
Nintedanib | Boehringer Ingelheim | chronic fibrosing interstitial lung diseases
Ipilimumab | Bristol-Myers Squibb | hepatocellular carcinoma
Nivolumab | Bristol-Myers Squibb | hepatocellular carcinoma
Selumetinib | AstraZeneca | neurofibromatosis type 1
Mitomycin | Urogen Pharma | upper tract urothelial cancer
Tucatinib | Seattle Genetics | advanced unresectable or metastatic HER2-positive breast cancer
Pemigatinib | Incyte Corp | metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion
Trodelvy | Immunomedics | metastatic triple-negative breast cancer
Capmatinib | Novartis | metastatic non-small cell lung cancer
Selpercatinib | Loxo Oncology | metastatic RET fusion-positive non-small cell lung cancer
Ripretinib | Deciphera Pharmaceuticals | advanced gastrointestinal stromal tumor
Artesunate | Amivas LLC | severe malaria
Bevacizumab | Genentech | metastatic hepatocellular carcinoma
Atezolizumab | Genentech | metastatic hepatocellular carcinoma
Inebilizumab | Viela Bio | neuromyelitis optica spectrum disorder
Fostemsavir | Viiv Healthcare Co | multidrug-resistant HIV-1
Monjuvi | MorphoSys | relapsed or refractory diffuse large B-cell lymphoma
Esketamine | Janssen | major depressive disorder with acute suicidal ideation or behavior[1]
Blenrep | GlaxoSmithKline | refractory multiple myeloma
Enspryng | Genentech | neuromyelitis optica spectrum disorder
Pralsetinib | Blueprint Medicines Corp | RET fusion-positive non-small cell lung cancer

D-PLEX 100 || PolyPid Ltd|| Prevention of Surgical Site Infections (SSI)

## 2019

Drug | Manufacturer | Indication

|
|

Psilocybin | Usona Institute | major depressive disorder[2]
B38M (JNJ‐4528)  | Legend Biotech/Janssen  | multiple myeloma
Rilonacept | Kiniska Pharmaceuticals  | recurrent pericarditis
Inmazeb  | Regeneron  | Ebola Virus
Olorofim | F2G  | invasive mold infections
Nintedanib | Boehringer Ingelheim  | interstitial lung disease
Niraparib | Janssen  | castration-resistant prostate cancer
Cobimetinib | Memorial Sloan Kettering  | histiocytic neoplasms
Tepotinib | Merck  | metastatic non-small cell lung cancer
Ansuvimab | Ridgeback Biotherapeutics  | Ebola Virus
Capmatinib | Novartis | metastatic non-small cell lung cancer
Nirogacestat  | SpringWorks Therapeutics  | refractory desmoid tumors
Bempegaldesleukin | Nektar Therapeutics  | melanoma
Peginterferon Lambda  | Eiger BioPharmaceuticals  | hepatitis delta virus infection
Acalabrutinib | AstraZeneca | chronic lymphocytic leukemia
Trilaciclib  | G1 Therapeutics  | small-cell lung cancer
Nedosiran  | Dicerna Pharmaceuticals  | primary hyperoxaluria
Pembrolizumab | Merck  | hepatocellular carcinoma
Avexitide  | Eiger BioPharmaceuticals  | post-bariatric hypoglycemia
Copanlisib | Bayer | marginal zone lymphoma
LN-145  | Iovance Biotherapeutics  | cervical cancer
Trastuzumab deruxtecan | Daiichi Sankyo  | HER2-positive breast cancer
SER-109  | Seres Therapeutics  | Clostridioides difficile infection
I.V. Artesunate | La Jolla Pharmaceutical  | malaria
Elafibranor | Genfit  | primary biliary cholangitis
Inebilizumab | Viela Bio  | neuromyelitis optica spectrum disorder
Bentracimab  | PhaseBio Pharmaceuticals  | reversal agent for ticagrelor
Selumetinib | AstraZeneca/Merck  | pediatric neurofibromatosis type 1
AXS-05  | Axsome Therapeutics  | major depressive disorder
ivosidenib | Agios Pharmaceuticals  | acute myeloid leukemia
Venetoclax | Abbvie | chronic lymphocytic leukemia
AT-GAA  | Amicus Therapeutics | Pompe disease
Pralsentinib | Blueprint Medicines  | Non-small cell lung cancer
Seladelpar | CymaBay Therapeutics  | primary biliary cholangitis
CP101  | Finch Therapeutics  | Clostridioides difficile infection
Nirsevimab  | AstraZeneca | respiratory syncytial virus
Kadcyla  | Genentech | HER2-positive breast cancer
Umbralisib | TG Therapeutics  | marginal-zone lymphoma
V114  | Merck  | pneumococcal disease
Zanubrutinib | BeiGene USA  | mantle cell lymphoma
Crizanlizumab | Novartis | sickle cell disease
Encorafenib | Array BioPharma | metastatic colorectal cancer

[3]

## 2018

Drug | Manufacturer | Indication

|
|

Tezacaftor/ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis
Durvalumab[1] | AstraZeneca UK  | unresectable Stage III non-small cell lung cancer (NSCLC)
Ibalizumab-uiyk[1] | Theratechnologies  | human immunodeficiency virus type 1 (HIV-1) infection
Brentuximab vedotin[1] | Seattle Genetics  | Hodgkin lymphoma
Ipilimumab[1] | Bristol-Myers Squibb | renal cell carcinoma
Nivolumab[1] | Bristol-Myers Squibb | renal cell carcinoma
Burosumab-twza[1] | Kyowa Hakko Kirin  | X-linked hypophosphatemia
Osimertinib[1] | AstraZeneca | metastatic non-small cell lung cancer
Dabrafenib[1] | Novartis Pharmaceuticals  | melanoma with BRAF V600E or V600K mutations
Trametinib[1] | Novartis Pharmaceuticals  | melanoma with BRAF V600E or V600K mutations
Dabrafenib[1] | Novartis Pharmaceuticals  | anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Trametinib[1] | Novartis Pharmaceuticals  | anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Fingolimod[1] | Novartis Pharmaceuticals  | multiple sclerosis
Rituximab[1] | Genentech | pemphigus vulgaris
Venetoclax[1] | AbbVie | chronic lymphocytic leukemia
Pembrolizumab[1] | Merck Sharp & Dohme  | mediastinal large B-cell lymphoma
Ipilimumab[1] | Bristol-Myers Squibb | metastatic colorectal cancer
Nivolumab[1] | Bristol-Myers Squibb | metastatic colorectal cancer
Ribociclib[1] | Novartis Pharmaceuticals  | breast cancer
Tafenoquine[1] | GlaxoSmithKline | Plasmodium vivax malaria
Iobenguane i 131[1] | Progenics Pharmaceuticals  | pheochromocytoma or paraganglioma
Lumacaftor/ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis
Mogamulizumab-kpkc[1] | Kyowa Hakko Kirin  | mycosis fungoides (MF) or Sézary syndrome (SS)
Patisiran[1] | Alnylam Pharmaceuticals  | hereditary transthyretin-mediated amyloidosis
Cenegermin-bkbj[1] | Dompe Farmaceutici  | neurotrophic keratitis
Lanadelumab-flyo[1] | Takeda Pharmaceuticals  | hereditary angioedema
Cemiplimab-rwlc[1] | Regeneron Pharmaceuticals  | cutaneous squamous cell carcinoma
Amikacin liposome inhalation suspension[1] | Insmed  | mycobacterial lung disease
Emicizumab-kxwh[1] | Genentech | hemophilia
Lorlatinib[1] | Pfizer | anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Brentuximab vedotin[1] | Seattle Genetics  | anaplastic large-cell lymphoma
Eltrombopag[1] | Novartis Pharmaceuticals  | severe aplastic anemia
Emapalumab-lzsg[1] | Swedish Orphan Biovitrum  | hemophagocytic lymphohistiocytosis
Venetoclax[1] | AbbVie | acute myeloid leukemia
Larotrectinib[1] | Bayer Healthcare  | solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Larotrectinib[1] | Bayer Healthcare  | solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Amifampridine[1] | Catalyst Pharmaceuticals | Lambert-Eaton myasthenic syndrome
Pembrolizumab[1] | Merck Sharp & Dohme  | Merkel cell carcinoma
Tagraxofusp-erzs[1] | Stemline Therapeutics  | blastic plasmacytoid dendritic cell neoplasm
Psilocybin | COMPASS Pathways | treatment resistant depression[4][5]
Satralizumab | Genentech | neuromyelitis optica spectrum disorder[citation needed]
Olipudase alfa | Sanofi/Genzyme | rare inherited disorders[citation needed]
Lonafarib | Eiger BioPharmaceuticals  | Hutchinson-Gilford progeria syndrome[citation needed]
Eltrombopag | Novartis | thrombocytopenia[citation needed]
Galcanezumab | Eli Lilly | episodic cluster headache[citation needed]
NRX-101 (Cyclurad)  | NRx Pharmaceuticals  | bipolar depression with suicidal ideation[6]
Mitomycin C | UroGen Pharma  | urothelial cancer[citation needed]
Myrcludex  | MYR Pharma  | hepatitis delta[citation needed]
Belumosudil | Kadmon Holdings  | graft-versus-host disease[citation needed]
Selpercatinib | Loxo Oncology
Selpercatinib | Loxo Oncology  | Non-small cell lung cancer[citation needed]
Rucaparib | Clovis Oncology  | castration-resistant prostate cancer[citation needed]
PF-06482077  | Pfizer
Vocacapsaicin  | Concentric Analgesics
Tezepelumab | AstraZeneca/Amgen
Ritlecitinib  | Pfizer | alopecia areata[citation needed]
Danyelza | Y-mAbs Therapeutics
Omalizumab | Genentech | severe allergic reactions[citation needed]
Encorafenib | Array BioPharma/Eli Lilly | colorectal cancer[citation needed]
Quizartinib | Daiichi Sankyo  | acute myeloid leukemia[citation needed]
Pembrolizumab | Merck  | endometrial carcinoma[citation needed]
Lenvatinib | Eisai  | endometrial carcinoma[citation needed]
Bevacizumab | Genentech | hepatocellular carcinoma[citation needed]
Atezolizumab | Genentech | hepatocellular carcinoma[citation needed]
AMT-601  | uniQure  | hemophilia B[citation needed]
HTX-011  | Heron Therapeutics  | Postoperative Pain[citation needed]
Crizotinib | Pfizer | anaplastic large cell lymphoma[citation needed]
Crizotinib | Pfizer | small-cell lung cancer[citation needed]
Tafamidis meglumine | Foldrx Pharmaceuticals
Lenti-D  | Bluebird bio  | cerebral adrenoleukodystrophy[citation needed]
Tafamidis | Pfizer | transthyretin cardiomyopathy[citation needed]
Pitolisant | Harmony Biosciences
Trikafta  | Vertex Pharmaceuticals | cystic fibrosis[citation needed]
Narsoplimab  | Omeros Corporation  | thrombotic microangiopathy[citation needed]
Trumenba | Pfizer | meningococcal disease[citation needed]
Esketamine | Johnson & Johnson  | depression[1]
Sodium thiosulfate | Fennec Pharmaceuticals
Enfortumab vedotin | Astellas Pharma  | metastatic urothelial carcinoma[citation needed]
Nesolicaftor  | Proteostasis Therapeutics  | cystic fibrosis[citation needed]
Erdafitinib | Janssen  | urothelial carcinoma[citation needed]
Lumasiran | Alnylam Pharmaceuticals  | primary hyperoxaluria[citation needed]
Sutimlimab | Bioverativ  | cold agglutinin disease[citation needed]
Avasopasem manganese  | Galera Therapeutics  | oral mucositis[citation needed]
SPK-8011  | Spark Therapeutics
Abrocitinib | Pfizer | atopic dermatitis[citation needed]
Zuranolone | Sage Therapeutics  | major depressive disorder[citation needed]
Fenfluramine | Zogenix  | seizures associated with Dravet syndrome[citation needed]
Balovaptan | Hoffman-La Roche | autism spectrum disorder[citation needed]
Kisquali Femara Co-Pack  | Novartis | HR-positive, HER2- negative breast cancer[citation needed]
Upadacitinib | AbbVie | atopic dermatitis[citation needed]
Lenvatinib \+ Pembrolizumab | Merck/Eisai  | metastatic renal cell carcinoma[citation needed]
Voxelotor | Global Blood Therapeutics  | sickle cell disease[citation needed]
Maribavir | Shire | Cytomegalovirus infection[citation needed]

[7]

## 2017

[8]

Drug | Manufacturer | Indication

|
|

Nivolumab[1] | Bristol-Myers Squibb | urothelial carcinoma
Ribociclib[1] | Novartis Pharmaceuticals | HR-positive, HER2-negative breast cancer
Pembrolizumab[1] | Merck Sharp & Dohme | Hodgkin Lymphoma
Avelumab[1] | EMD Serono | metastatic Merkel cell carcinoma
Niraparib[1] | GlaxoSmithKline | recurrent ovarian cancer responsive to platinum-based chemotherapy
Ocrelizumab[1] | Genentech | multiple sclerosis
Dupilumab[1] | Regeneron Pharmaceuticals | atopic dermatitis
Palbociclib[1] | Pfizer | HR-positive, HER2-negative breast cancer
Valbenazine[1] | Neurocrine Biosciences | tardive dyskinesia
Ranibizumab[1] | Genentech | diabetic retinopathy
Cerliponase alfa[1] | BioMarin Pharmaceutical | tripeptidyl peptidase 1 (TPP1) deficiency
Midostaurin[1] | Novartis Pharmaceuticals | FLT3-positive acute myeloid leukemia
Brigatinib[1] | Takeda Pharmaceuticals | ALK-positive non-small cell lung cancer
Durvalumab[1] | AstraZeneca UK | metastatic urothelial carcinoma
Letrozole with Ribociclib[1] | Novartis Pharmaceuticals | breast cancer
Pembrolizumab[1] | Merck Sharp & Dohme | urothelial carcinoma
Tocilizumab[1] | Genentech | giant cell arteritis
Pembrolizumab[1] | Merck Sharp & Dohme | microsatellite instability-high tumors
Ceritinib[1] | Novartis Pharmaceuticals | anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Dabrafenib[1] | Novartis Pharmaceuticals | metastatic non-small cell lung cancer with BRAF V600E mutation
Trametinib[1] | Novartis Pharmaceuticals | metastatic non-small cell lung cancer with BRAF V600E mutation
Ibrutinib[1] | Pharmacyclics | chronic graft versus host disease (cGVHD)
Glecaprevir/pibrentasvir[1] | AbbVie | hepatitis C
Cytarabine/daunorubicin[1] | Celator Pharmaceuticals | acute myeloid leukemia
Inotuzumab ozogamicin[1] | Wyeth Pharmaceuticals | B-cell precursor acute lymphoblastic leukemia
Deutetrabenazine[1] | Teva Pharmaceuticals | tardive dyskinesia
Abemaciclib[1] | Eli Lilly | breast cancer
Acalabrutinib[1] | AstraZeneca UK | mantle cell lymphoma
Vemurafenib[1] | Hoffmann-La Roche | Erdheim-Chester disease with BRAF V600 mutation
Alectinib[1] | Hoffmann-La Roche | anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)
Letermovir[1] | Merck Sharp & Dohme | cytomegalovirus (CMV) infection
Letermovir[1] | Merck Sharp & Dohme | cytomegalovirus (CMV) infection
Brentuximab vedotin[1] | Seattle Genetics | anaplastic large-cell lymphoma
Emicizumab-kxwh[1] | Genentech | hemophilia
Nivolumab[1] | Bristol-Myers Squibb | melanoma
Ribaxamase | Synthetic Biologics | antibiotic resistance / Clostridioides difficile infection
Midomafetamine (Ecstasy) | Multidisciplinary Association for Psychedelic Studies | posttraumatic stress disorder[9][10]

## 2016

Drug | Manufacturer | Indication

|
|

Elbasvir/grazoprevir[1] | Merck Sharp & Dohme | Hepatitis C
Palbociclib[1] | Pfizer | HR-positive, HER2-negative breast cancer
Crizotinib[1] | PF Prism | ROS-1-positive NSCLC
Venetoclax[1] | AbbVie | CLL with 17p deletion
Cabozantinib[1] | Exelixis | renal cell carcinoma
Pimavanserin[1] | Acadia Pharmaceuticals | Parkinson's disease-related psychosis
Ibrutinib[1] | Pharmacyclics | small lymphocytic lymphoma (SLL) with 17p deletion
Lenvatinib[1] | Eisai | renal cell carcinoma
Nivolumab[1] | Bristol-Myers Squibb | Hodgkin lymphoma
Atezolizumab[1] | Genentech | urothelial carcinoma
Sofosbuvir/velpatasvir[1] | Gilead Sciences | chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6 infection
Canakinumab[1] | Novartis | Familial mediterranean fever
Canakinumab[1] | Novartis | Hyper-IgD syndrome
Canakinumab[1] | Novartis | TNF receptor associated periodic syndrome
Lumacaftor/ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis with CFTR F508del
Atezolizumab[1] | Genentech | metastatic NSCLC
Olaratumab[1] | Eli Lilly | soft-tissue sarcoma
Pembrolizumab | Merck Sharp & Dohme | metastatic NSCLC
Nivolumab[1] | Bristol-Myers Squibb | head and neck cancer
Daratumumab[1] | Janssen | multiple myeloma
Daratumumab[1] | Janssen | multiple myeloma
Oliceridine | Trevena | Analgesia and pain management
Rucaparib[1] | Clovis Oncology | BRCA-mutated ovarian cancer
Silver diamine fluoride | Elevate Oral Care | early childhood caries

## 2015

Drug | Manufacturer | Indication

|
|

Ibrutinib[1] | Pharmacyclics | Waldenstrom’s macroglobulinemia
Palbociclib[1] | Pfizer | ER-positive, HER2-negative breast cancer
Ranibizumab[1] | Genentech | diabetic retinopathy
Ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis with a variety of CFTR mutations
Aflibercept[1] | Regeneron Pharmaceuticals | diabetic retinopathy
Sirolimus[1] | PF Prism | lymphangioleiomyomatosis
Sirolimus[1] | PF Prism | lymphangioleiomyomatosis
Lumacaftor/ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis with CFTR F508del mutation
Ombitasvir/paritaprevir/ritonavir[1] | AbbVie | Hepatitis C
Uridine triacetate[1] | Wellstat Therapeutics | hereditary orotic aciduria
Pembrolizumab[1] | Merck Sharp & Dohme | PDL-1 positive NSCLC
Nivolumab[1] | Bristol-Myers Squibb | metastatic NSCLC
Idarucizumab[1] | Boehringer Ingelheim | reversal of dabigatran
Asfotase alfa[1] | Alexion Pharmaceuticals | perinatal/infantile/childhood hypophosphatasia
Osimertinib[1] | AstraZeneca | EGFR-positive NSCLC
Daratumumab[1] | Janssen Biotech | multiple myeloma
Nivolumab[1] | Bristol-Myers Squibb | advanced renal cell carcinoma
Elotuzumab[1] | Bristol-Myers Squibb | multiple myeloma
Sebelipase alfa[1] | Alexion Pharmaceuticals | lysosomal acid lipase deficiency
Alectinib[1] | Hoffmann-La Roche | ALK-mutated NSCLC
Pembrolizumab[1] | Merck Sharp & Dohme | metastatic melanoma
Ibalizumab[11] | TaiMed Biologics | HIV-1 infection

## 2014

Drug | Manufacturer | Indication

|
|

Ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis with CFTR mutation
Ofatumumab[1] | Novartis Pharmaceuticals | chronic lymphocytic leukemia (CLL)
Ceritinib[1] | Novartis Pharmaceuticals | anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Idelalisib[1] | Gilead Sciences | relapsed chronic lymphocytic leukemia (CLL)
Ibrutinib[1] | Pharmacyclics | chronic lymphocytic leukemia (CLL) with 17p deletion
Eltrombopag[1] | Novartis Pharmaceuticals | aplastic anemia
Pembrolizumab[1] | Merck | metastatic melanoma
Ledipasvir/sofosbuvir[1] | Gilead Sciences | Hepatitis C
Pirfenidone[1] | Genentech | idiopathic pulmonary fibrosis
Nintedanib[1] | Boehringer Ingelheim | idiopathic pulmonary fibrosis
Blinatumomab[1] | Amgen | acute lymphoblastic leukemia
Ombitasvir/paritaprevir/ritonavir/dasabuvir[1] | AbbVie | Hepatitis C
Nivolumab[1] | Bristol-Myers Squibb[1] | metastatic melanoma
Ivacaftor[1] | Vertex Pharmaceuticals | cystic fibrosis with CFTR R117H mutation

## 2013

Drug | Manufacturer | Indication

|
|

Obinutuzumab[1] | Genentech | chronic lymphocytic leukemia
Ibrutinib[1] | Pharmacyclics | mantle cell lymphoma
Sofosbuvir[1] | Gilead Sciences | Hepatitis C

## References

1. ↑ 1.000 1.001 1.002 1.003 1.004 1.005 1.006 1.007 1.008 1.009 1.010 1.011 1.012 1.013 1.014 1.015 1.016 1.017 1.018 1.019 1.020 1.021 1.022 1.023 1.024 1.025 1.026 1.027 1.028 1.029 1.030 1.031 1.032 1.033 1.034 1.035 1.036 1.037 1.038 1.039 1.040 1.041 1.042 1.043 1.044 1.045 1.046 1.047 1.048 1.049 1.050 1.051 1.052 1.053 1.054 1.055 1.056 1.057 1.058 1.059 1.060 1.061 1.062 1.063 1.064 1.065 1.066 1.067 1.068 1.069 1.070 1.071 1.072 1.073 1.074 1.075 1.076 1.077 1.078 1.079 1.080 1.081 1.082 1.083 1.084 1.085 1.086 1.087 1.088 1.089 1.090 1.091 1.092 1.093 1.094 1.095 1.096 1.097 1.098 1.099 1.100 1.101 1.102 1.103 1.104 1.105 1.106 1.107 1.108 1.109 1.110 1.111 1.112 1.113 1.114 1.115 1.116 1.117 1.118 1.119 1.120 1.121 1.122 1.123 1.124 1.125 1.126 1.127 1.128 1.129 1.130 1.131 1.132 1.133 1.134 1.135 (PDF) CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2021. U.S. Food and Drug Administration (FDA). https://www.fda.gov/media/95302/download. This article incorporates text from this source, which is in the public domain.
2. ↑ "FDA Grants Psilocybin Second Breakthrough Therapy Designation". https://www.medscape.com/viewarticle/921789. Retrieved 5 January 2020.
3. ↑ Research, Center for Drug Evaluation and (2020-10-08). "Breakthrough Therapy Approvals" (in en). FDA. https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals.
4. ↑ "COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression". COMPASS Pathways. October 23, 2018. https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html.
5. ↑ "FDA Puts 'Magic Mushroom' Ingredient on Fast Track for Depression Treatment". www.healthline.com. November 7, 2018. https://www.healthline.com/health-news/fda-looking-at-magic-mushroom-ingredient-to-treat-depression.
6. ↑ "NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation | Clinical Research Trial Listing ( Bipolar Depression | Suicidal Ideation ) ( NCT03396068 )". https://www.centerwatch.com/clinical-trials/listings/225445/nrx-101-for-maintenance-of-remission-from-severe-bipolar-depression-in-patients-with-suicidal-ideation/.
7. ↑ "Breakthrough Therapy Approvals". FDA. 2020-10-08. https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals.
8. ↑ "Approval report". https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM494010.pdf.
9. ↑ "FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD". maps.org. August 26, 2017. https://maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials.
10. ↑ "Ecstasy as a Remedy for PTSD? You Probably Have Some Questions.". The New York Times. May 1, 2018. https://www.nytimes.com/2018/05/01/us/ecstasy-molly-ptsd-mdma.html.
11. ↑ https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000AdminCorres.pdf [bare URL PDF]

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