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Longer titles found: List of drugs granted breakthrough therapy designation (view)

searching for Breakthrough therapy 53 found (207 total)

Psychedelic therapy (8,147 words) [view diff] exact match in snippet view article find links to article

disorder. The United States Food and Drug Administration has granted "breakthrough therapy" status, which expedites the assessment of promising drug therapies

Blinatumomab (995 words) [view diff] exact match in snippet view article find links to article

furthered the drug's clinical trials. In July 2014, the FDA granted breakthrough therapy status to blinatumomab for the treatment of acute lymphoblastic leukemia

Bimagrumab (365 words) [view diff] exact match in snippet view article find links to article

August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US

Spectrum Pharmaceuticals (1,093 words) [view diff] case mismatch in snippet view article find links to article

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

Pritelivir (1,008 words) [view diff] case mismatch in snippet view article find links to article

granted Fast Track Designation for pritelivir in 2017. US FDA granted Breakthrough Therapy Designation for pritelivir in 2020. Pritelivir is also known as AIC316

Protein kinase inhibitor (742 words) [view diff] exact match in snippet view article find links to article

Institute. Retrieved April 20, 2018. "Janssen announces U.S. FDA breakthrough therapy designation for erdafitinib in the Treatment of metastatic urothelial

Ibalizumab (735 words) [view diff] exact match in snippet view article find links to article

drug designation for HIV MDR patients by U.S. FDA. 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA. 2015: initiated

Psychedelic drug (8,406 words) [view diff] exact match in snippet view article find links to article

illness. The United States Food and Drug Administration has granted "breakthrough therapy" status, which expedites the assessment of promising drug therapies

Zydus Lifesciences (1,168 words) [view diff] exact match in snippet view article find links to article

Standard India. Retrieved 17 March 2022. "Zydus launches SoviHep - the breakthrough therapy for Hepatitis C in alliance with Gilead Sciences". The Hindu Business

Psilocybin decriminalization in the United States (4,854 words) [view diff] exact match in snippet view article find links to article

October 2018, the Food and Drug Administration granted psilocybin "breakthrough therapy" status for research. The drug was granted this status again in November

Tezepelumab (1,017 words) [view diff] case mismatch in snippet view article find links to article

1007/s40265-020-01273-4. PMID 32078149. S2CID 211194472. "Tezepelumab granted Breakthrough Therapy Designation by US FDA". AstraZeneca (Press release). 7 September

Trevena Inc (1,269 words) [view diff] case mismatch in snippet view article find links to article

therapeutic window than morphine. In February 2016, the FDA granted Breakthrough Therapy status to olicerdine. In January 2017, Trevena announced that enrollment

Paul Negulescu (1,505 words) [view diff] exact match in snippet view article find links to article

October 12, 2022. Retrieved October 18, 2022. "FDA approves new breakthrough therapy for cystic fibrosis" (Press release). Food and Drug Administration

Crystal Mackall (2,782 words) [view diff] case mismatch in snippet view article find links to article

CAR targeting CD22 that is active in this disease and has received Breakthrough Therapy Designation from the US FDA for treatment of CAR19 refractory B-ALL

Cystic fibrosis (17,980 words) [view diff] exact match in snippet view article find links to article

com. Office of the Commissioner (24 March 2020). "FDA approves new breakthrough therapy for cystic fibrosis". FDA. Retrieved 28 April 2022. "FDA Accepts

Synageva (794 words) [view diff] case mismatch in snippet view article find links to article

Welfare. Kanuma also received fast track designation by the FDA, and Breakthrough Therapy designation by the FDA for LAL Deficiency presenting in infants.

Lasmiditan (1,409 words) [view diff] case mismatch in snippet view article find links to article

the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality (galcanezumab-gnlm) for Prevention of Episodic

Elexacaftor (286 words) [view diff] exact match in snippet view article find links to article

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

Merck & Co. (9,333 words) [view diff] exact match in snippet view article find links to article

Drug Administration (FDA) approved Pembrolizumab (MK-3475) as a breakthrough therapy for melanoma treatment. In clinical trials, pembrolizumab provided

Ceritinib (1,239 words) [view diff] case mismatch in snippet view article find links to article

NSCLC with ALK-positive tumors. Additionally, the FDA also gave Breakthrough Therapy designation to the drug for ALK-positive metastatic NSCLC that has

Setmelanotide (1,407 words) [view diff] exact match in snippet view article find links to article

granted the application for setmelanotide orphan disease designation, breakthrough therapy designation, and priority review. The FDA granted the approval of

Vertex Pharmaceuticals (3,315 words) [view diff] exact match in snippet view article find links to article

Against Cystic Fibrosis". Forbes. 18 July 2017. "FDA approves new breakthrough therapy for cystic fibrosis". FDA. 21 October 2019. Parsons, Lucy (24 October

MYK-224 (136 words) [view diff] case mismatch in snippet view article find links to article

Inderbir; Lehr, Eric J.; Johal, Gurpreet (September 2023). "Aficamten: A Breakthrough Therapy for Symptomatic Obstructive Hypertrophic Cardiomyopathy". American

Jazz Pharmaceuticals (906 words) [view diff] exact match in snippet view article find links to article

Pharmaceuticals for $1.5 billion. As a result, Jazz obtained the rights to breakthrough therapy Vyxeos (liposomal daunorubicin and cytarabine) for treatment of acute

Trace amine-associated receptor (2,036 words) [view diff] case mismatch in snippet view article find links to article

"Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia". news

Antidepressant (20,467 words) [view diff] case mismatch in snippet view article find links to article

Breakthrough Therapy Designation for psilocybin-assisted therapy for treatment-resistant depression and in 2019, the FDA granted Breakthrough Therapy

Friends of Cancer Research (496 words) [view diff] case mismatch in snippet view article find links to article

2012, Friends of Cancer Research led the development of the FDA's Breakthrough Therapy designation, an expedited review pathway for drugs that show clinical

Margaret Shipp (518 words) [view diff] exact match in snippet view article find links to article

which prompted the Food and Drug Administration to designate it a "breakthrough therapy" for treating relapsed Hodgkin lymphoma. By the start of 2017, nivolumab

Tezacaftor (724 words) [view diff] exact match in snippet view article find links to article

DailyMed. 29 January 2020. Retrieved 22 August 2020. "FDA approves new breakthrough therapy for cystic fibrosis". U.S. Food and Drug Administration (FDA) (Press

Orphan drug (4,197 words) [view diff] exact match in snippet view article find links to article

(PLAN). The FDA granted Patisiran (Onpattro) orphan drug status and breakthrough therapy designation due to its novel mechanism involving RNA therapy to block

Biogen (3,702 words) [view diff] case mismatch in snippet view article find links to article

lymphocytic leukemia 2013 2014 The first medicine approved with the FDA's Breakthrough Therapy Designation and is also currently in Phase 3 trials for NHL and diffuse

Nirsevimab (1,905 words) [view diff] case mismatch in snippet view article find links to article

Equity Research (25 March 2022). "Pfizer's (PFE) RSV Jab Gets Another Breakthrough Therapy Tag". Nasdaq. Archived from the original on 8 April 2022. Retrieved

Serelaxin (1,043 words) [view diff] exact match in snippet view article find links to article

in signs and symptoms of congestion. The FDA granted serelaxin "breakthrough therapy" designation, meant to expedite the development and review of drugs

Sakigake (drug designation) (316 words) [view diff] case mismatch in snippet view article

Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States". Therapeutic Innovation & Regulatory

Novimmune (361 words) [view diff] case mismatch in snippet view article find links to article

tumors. No drugs have been approved yet. "Novimmune's NI-0501 Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients With Primary Hemophagocytic

Roche (5,224 words) [view diff] case mismatch in snippet view article find links to article

companies Pharmaceutical industry in Switzerland "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug". BioPharm International. UBM. 19

Francine Shapiro (1,446 words) [view diff] case mismatch in snippet view article find links to article

ISBN 1-59486-425-X Shapiro, F & Forrest, M S (2004). EMDR: The Breakthrough Therapy for Overcoming Anxiety, Stress and Trauma. Basic books. ISBN 0-465-04301-1

Nintedanib (3,010 words) [view diff] exact match in snippet view article find links to article

Administration (FDA) granted nintedanib priority review designation and breakthrough therapy designation. The FDA granted the approval of Ofev to Boehringer Ingelheim

Small interfering RNA (6,760 words) [view diff] case mismatch in snippet view article find links to article

limited. After the approval of Onpattro, FDA awarded Alnylam with the Breakthrough Therapy Designation, which is given to drugs that are intended to treat a

Psychotraumatology (1,069 words) [view diff] exact match in snippet view article find links to article

needed] MDMA-assisted therapy for Complex PTSD *(The FDA gave the Breakthrough therapy designation and it legal use is only available in the USA) Phase

Epidermal growth factor receptor (6,879 words) [view diff] case mismatch in snippet view article find links to article

brigatinib targeting the T790M mutation, and brigatinib received Breakthrough Therapy designation status by FDA in Feb. 2015. The most common adverse effect

Oculesics (4,518 words) [view diff] exact match in snippet view article find links to article

Retrieved 4 June 2012. Shapiro, F.; Forrest, M. S. (1997). EMDR: The breakthrough therapy for overcoming anxiety, stress and trauma. New York: Basic Books

Aficamten (333 words) [view diff] case mismatch in snippet view article find links to article

Inderbir; Lehr, Eric J.; Johal, Gurpreet (September 2023). "Aficamten: A Breakthrough Therapy for Symptomatic Obstructive Hypertrophic Cardiomyopathy". American

Volasertib (1,758 words) [view diff] case mismatch in snippet view article find links to article

1634/theoncologist.2009-0010. PMID 19474163. "Volasertib* receives FDA Breakthrough Therapy designation for treatment of patients with acute myeloid leukaemia"

Katherine A. High (1,439 words) [view diff] case mismatch in snippet view article find links to article

therapeutic (Luxturna®) in December 2017 and led the team that obtained Breakthrough Therapy designations for three product candidates, SPK-RPE65 (Luxturna®)

Prostate Cancer Foundation (2,471 words) [view diff] exact match in snippet view article find links to article

Safeway Foundation fast-forwarded the research and development of the breakthrough therapy Xofigo, which is used to put metastatic bone tumors into remission

Treatments for PTSD (13,812 words) [view diff] case mismatch in snippet view article find links to article

2022-06-15. "Breakthrough Therapy". Food and Drug Administration. 4 January 2018. Wan W (26 August 2017). "Ecstasy could be 'breakthrough' therapy for soldiers

Cancer immunotherapy (9,943 words) [view diff] case mismatch in snippet view article find links to article

November 2013. "Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal

Peter Grootenhuis (964 words) [view diff] exact match in snippet view article find links to article

2020-07-21. Commissioner, Office of the (2020-03-24). "FDA approves new breakthrough therapy for cystic fibrosis". FDA. Retrieved 2020-07-21. "Peter D.J. Grootenhuis

Jeffrey Leiden (2,261 words) [view diff] exact match in snippet view article find links to article

Forbes. Commissioner, Office of the (2019-10-24). "FDA approves new breakthrough therapy for cystic fibrosis". FDA. Retrieved 2019-10-25. "1st Patients To

Pharmaceutical innovations (2,230 words) [view diff] case mismatch in snippet view article find links to article

development has been coined as Eroom's Law. The FDA has implemented the Breakthrough Therapy Designation which should help bring new needed products to the market

José-Alain Sahel (2,102 words) [view diff] exact match in snippet view article find links to article

the Research on visual prostheses that could potentially become a breakthrough therapy for visually disabled patients, and allow them to regain some autonomy

Matthias Gromeier (1,515 words) [view diff] exact match in snippet view article find links to article

and renal cancers. In May 2016, Gromier's therapy was granted "breakthrough therapy designation" by the Food and Drug Administration, indicating that