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Priority review, the Glossary

Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease.^[1]

122 relations: AbbVie, Acute lymphoblastic leukemia, African trypanosomiasis, Alexion Pharmaceuticals, Alirocumab, Allogeneic processed thymus tissue, Alnylam Pharmaceuticals, Amgen, Artemether/lumefantrine, Asfotase alfa, Astex Pharmaceuticals, Bavarian Nordic, Bedaquiline, Benznidazole, Bill Gates, Biologics license application, BioMarin Pharmaceutical, Breakthrough therapy, Burosumab, Buruli ulcer, Cannabidiol, Capmatinib, Cerliponase alfa, Chagas disease, Chikungunya, Cholera, Cholera vaccine, Cholic acid, Chronic myelomonocytic leukemia, Congenital athymia, Cryptococcosis, Cystic fibrosis, Deflazacort, Dengue fever, Dengue vaccine, Dinutuximab, Dracunculiasis, Drug development, Duchenne muscular dystrophy, Ebola, Elapegademase, Elexacaftor/tezacaftor/ivacaftor, Eli Lilly, Elosulfase alfa, Emapalumab, Eteplirsen, Fasciolosis, Fast track (FDA), Filoviridae, Food and Drug Administration, ... Expand index (72 more) »
Pharmaceutical regulation in the United States

AbbVie

AbbVie Inc. is an American pharmaceutical company headquartered in North Chicago, Illinois.

See Priority review and AbbVie

Acute lymphoblastic leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the lymphoid line of blood cells characterized by the development of large numbers of immature lymphocytes.

See Priority review and Acute lymphoblastic leukemia

African trypanosomiasis

African trypanosomiasis is an insect-borne parasitic infection of humans and other animals. Priority review and African trypanosomiasis are tropical diseases.

See Priority review and African trypanosomiasis

Alexion Pharmaceuticals

Alexion Pharmaceuticals, a subsidiary of AstraZeneca, is a pharmaceutical company headquartered in Boston, Massachusetts that specializes in orphan drugs to treat rare diseases.

See Priority review and Alexion Pharmaceuticals

Alirocumab

Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment.

See Priority review and Alirocumab

Allogeneic processed thymus tissue

Allogeneic processed thymus tissue, sold under the brand name Rethymic, is a thymus tissue medical therapy used for the treatment of children with congenital athymia.

See Priority review and Allogeneic processed thymus tissue

Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, Inc. is an American biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics for genetically defined diseases.

See Priority review and Alnylam Pharmaceuticals

Amgen

Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

See Priority review and Amgen

Artemether/lumefantrine

Artemether/lumefantrine, sold under the trade name Coartem among others, is a combination of the two medications artemether and lumefantrine.

See Priority review and Artemether/lumefantrine

Asfotase alfa

Asfotase alfa, sold under the brand name Strensiq, is a medication used in the treatment of people with perinatal/infantile- and juvenile-onset hypophosphatasia.

See Priority review and Asfotase alfa

Astex Pharmaceuticals

Astex Pharmaceuticals ("Astex") is a biotechnology company focused on the discovery and development of drugs in oncology and diseases of the central nervous system.

See Priority review and Astex Pharmaceuticals

Bavarian Nordic

Bavarian Nordic A/S is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of vaccines.

See Priority review and Bavarian Nordic

Bedaquiline

Bedaquiline, sold under the brand name Sirturo, is a medication used for the treatment of active tuberculosis.

See Priority review and Bedaquiline

Benznidazole

Benznidazole is an antiparasitic medication used in the treatment of Chagas disease.

See Priority review and Benznidazole

Bill Gates

William Henry Gates III (born October 28, 1955) is an American business magnate best known for co-founding the software company Microsoft with his childhood friend Paul Allen.

See Priority review and Bill Gates

Biologics license application

A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). Priority review and biologics license application are Food and Drug Administration.

See Priority review and Biologics license application

BioMarin Pharmaceutical

BioMarin Pharmaceutical Inc. is an American biotechnology company headquartered in San Rafael, California.

See Priority review and BioMarin Pharmaceutical

Breakthrough therapy

Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. Priority review and Breakthrough therapy are pharmaceutical regulation in the United States.

See Priority review and Breakthrough therapy

Burosumab

Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.

See Priority review and Burosumab

Buruli ulcer

Buruli ulcer is an infectious disease characterized by the development of painless open wounds. Priority review and Buruli ulcer are tropical diseases.

See Priority review and Buruli ulcer

Cannabidiol

Cannabidiol (CBD) is a phytocannabinoid discovered in 1940.

See Priority review and Cannabidiol

Capmatinib

Capmatinib, sold under the brand name Tabrecta, is an anticancer medication used for the treatment of metastatic non-small cell lung cancer whose tumors have a mutation that leads to the exon 14 skipping of the ''MET'' gene, which codes for the membrane receptor HGFR.

See Priority review and Capmatinib

Cerliponase alfa

Cerliponase alfa, marketed as Brineura, is an enzyme replacement treatment for Batten disease, a neurodegenerative lysosomal storage disease.

See Priority review and Cerliponase alfa

Chagas disease

Chagas disease, also known as American trypanosomiasis, is a tropical parasitic disease caused by Trypanosoma cruzi. Priority review and Chagas disease are tropical diseases.

See Priority review and Chagas disease

Chikungunya

Chikungunya is an infection caused by the Chikungunya virus (CHIKV). Priority review and Chikungunya are tropical diseases.

See Priority review and Chikungunya

Cholera

Cholera is an infection of the small intestine by some strains of the bacterium Vibrio cholerae. Priority review and cholera are tropical diseases.

See Priority review and Cholera

Cholera vaccine

A cholera vaccine is a vaccine that is effective at reducing the risk of contracting cholera.

See Priority review and Cholera vaccine

Cholic acid

Cholic acid, also known as 3α,7α,12α-trihydroxy-5β-cholan-24-oic acid is a primary bile acid that is insoluble in water (soluble in alcohol and acetic acid), it is a white crystalline substance.

See Priority review and Cholic acid

Chronic myelomonocytic leukemia

Chronic myelomonocytic leukemia (CMML) is a type of leukemia, which are cancers of the blood-forming cells of the bone marrow.

See Priority review and Chronic myelomonocytic leukemia

Congenital athymia

Congenital athymia is an extremely rare disorder marked by the absence of the thymus at birth.

See Priority review and Congenital athymia

Cryptococcosis

Cryptococcosis is a potentially fatal fungal infection of mainly the lungs, presenting as a pneumonia, and brain, where it appears as a meningitis.

See Priority review and Cryptococcosis

Cystic fibrosis

Cystic fibrosis (CF) is a genetic disorder inherited in an autosomal recessive manner that impairs the normal clearance of mucus from the lungs, which facilitates the colonization and infection of the lungs by bacteria, notably Staphylococcus aureus.

See Priority review and Cystic fibrosis

Deflazacort

Deflazacort (trade name Calcort among others) is a glucocorticoid belonging to acetonides or O-isopropylidene derivative.

See Priority review and Deflazacort

Dengue fever

Dengue fever is a mosquito-borne disease caused by dengue virus, prevalent in tropical and subtropical areas. Priority review and dengue fever are tropical diseases.

See Priority review and Dengue fever

Dengue vaccine

Dengue vaccine is a vaccine used to prevent dengue fever in humans.

See Priority review and Dengue vaccine

Dinutuximab

Dinutuximab (Ch14.18, tradename Unituxin) and dinutuximab beta (tradename Qarziba) are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma.

See Priority review and Dinutuximab

Dracunculiasis

Dracunculiasis, also called Guinea-worm disease, is a parasitic infection by the Guinea worm, Dracunculus medinensis. Priority review and Dracunculiasis are tropical diseases.

See Priority review and Dracunculiasis

Drug development

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.

See Priority review and Drug development

Duchenne muscular dystrophy

Duchenne muscular dystrophy (DMD) is a severe type of muscular dystrophy predominantly affecting boys.

See Priority review and Duchenne muscular dystrophy

Ebola

Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Priority review and ebola are tropical diseases.

See Priority review and Ebola

Elapegademase

Elapegademase, sold under the brand name Revcovi, is a medication for the treatment of the rare disease adenosine deaminase deficiency-SCID in children and adults.

See Priority review and Elapegademase

Elexacaftor/tezacaftor/ivacaftor

Elexacaftor/tezacaftor/ivacaftor, sold under the brand names Trikafta and Kaftrio, is a fixed-dose combination medication used to treat cystic fibrosis.

See Priority review and Elexacaftor/tezacaftor/ivacaftor

Eli Lilly

Eli Lilly (July 8, 1838 – June 6, 1898) was an Union Army officer, pharmacist, chemist, and businessman who founded Eli Lilly and Company.

See Priority review and Eli Lilly

Elosulfase alfa

Elosulfase alfa, sold under the brand name Vimizim, is a medication used for the treatment of Morquio syndrome which is caused by a deficiency in the enzyme N-acetylgalactosamine-6-sulfatase.

See Priority review and Elosulfase alfa

Emapalumab

Emapalumab, sold under the brand name Gamifant, is an anti-interferon-gamma (IFNγ) antibody medication used for the treatment of hemophagocytic lymphohistiocytosis (HLH), which has no cure. The most common side effects include infections, hypertension, infusion-related reactions, and pyrexia. The U.S.

See Priority review and Emapalumab

Eteplirsen

Eteplirsen (brand name Exondys 51) is a medication to treat, but not cure, some types of Duchenne muscular dystrophy (DMD), caused by a specific mutation.

See Priority review and Eteplirsen

Fasciolosis

Fasciolosis is a parasitic worm infection caused by the common liver fluke Fasciola hepatica as well as by Fasciola gigantica. Priority review and Fasciolosis are tropical diseases.

See Priority review and Fasciolosis

Fast track (FDA)

Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Priority review and Fast track (FDA) are Food and Drug Administration and pharmaceutical regulation in the United States.

See Priority review and Fast track (FDA)

Filoviridae

Filoviridae is a family of single-stranded negative-sense RNA viruses in the order Mononegavirales. Priority review and Filoviridae are tropical diseases.

See Priority review and Filoviridae

Food and Drug Administration

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.

See Priority review and Food and Drug Administration

Food and Drug Administration Amendments Act of 2007

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. Priority review and Food and Drug Administration Amendments Act of 2007 are Food and Drug Administration.

See Priority review and Food and Drug Administration Amendments Act of 2007

Food and Drug Administration Safety and Innovation Act

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. Priority review and Food and Drug Administration Safety and Innovation Act are Food and Drug Administration.

See Priority review and Food and Drug Administration Safety and Innovation Act

Golodirsen

Golodirsen, sold under the brand name Vyondys 53, is a medication used for the treatment of Duchenne muscular dystrophy.

See Priority review and Golodirsen

GSK plc

GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British multinational pharmaceutical and biotechnology company with global headquarters in London.

See Priority review and GSK plc

GW Pharmaceuticals

GW Pharmaceuticals Limited is a British pharmaceutics company known for its multiple sclerosis treatment product nabiximols (brand name, Sativex) which was the first natural cannabis plant derivative to gain market approval in any country.

See Priority review and GW Pharmaceuticals

Helminthiasis

Helminthiasis, also known as worm infection, is any macroparasitic disease of humans and other animals in which a part of the body is infected with parasitic worms, known as helminths. Priority review and Helminthiasis are tropical diseases.

See Priority review and Helminthiasis

Ionis Pharmaceuticals

Ionis Pharmaceuticals, Inc. is a biotechnology company based in Carlsbad, California, that specializes in discovering and developing RNA-targeted therapeutics.

See Priority review and Ionis Pharmaceuticals

Ivacaftor

Ivacaftor is a medication used to treat cystic fibrosis in people with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (primarily the G551D mutation), who account for 4–5% cases of cystic fibrosis.

See Priority review and Ivacaftor

Janssen Pharmaceuticals

Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals) is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson.

See Priority review and Janssen Pharmaceuticals

Kite Pharma

Kite Pharma is an American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.

See Priority review and Kite Pharma

Knight Therapeutics

Knight Therapeutics Inc. is a Canadian public specialty pharmaceutical company based in Montreal, Quebec that focuses on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets.

See Priority review and Knight Therapeutics

Lassa fever

Lassa fever, also known as Lassa hemorrhagic fever, is a type of viral hemorrhagic fever caused by the Lassa virus. Priority review and Lassa fever are tropical diseases.

See Priority review and Lassa fever

Leadiant Biosciences

Leadiant Biosciences, formerly known as Sigma-Tau Industrie Farmaceutiche Riunite, was founded in 1957 by research chemist Claudio Cavazza.

See Priority review and Leadiant Biosciences

Leishmaniasis

Leishmaniasis is a wide array of clinical manifestations caused by protozoal parasites of the Trypanosomatida genus Leishmania. Priority review and Leishmaniasis are tropical diseases.

See Priority review and Leishmaniasis

Lennox–Gastaut syndrome

Lennox–Gastaut syndrome (LGS) is a complex, rare, and severe childhood-onset epilepsy syndrome.

See Priority review and Lennox–Gastaut syndrome

Leprosy

Leprosy, also known as Hansen's disease (HD), is a long-term infection by the bacteria Mycobacterium leprae or Mycobacterium lepromatosis. Priority review and Leprosy are tropical diseases.

See Priority review and Leprosy

Lumasiran

Lumasiran, sold under the brand name Oxlumo, is a medication for the treatment of primary hyperoxaluria type 1 (PH1).

See Priority review and Lumasiran

Lymphatic filariasis

Lymphatic filariasis is a human disease caused by parasitic worms known as filarial worms. Priority review and Lymphatic filariasis are tropical diseases.

See Priority review and Lymphatic filariasis

Malaria

Malaria is a mosquito-borne infectious disease that affects vertebrates. Priority review and Malaria are tropical diseases.

See Priority review and Malaria

Marathon Pharmaceuticals

Marathon Pharmaceuticals LLC was a privately held biopharmaceuticals company focused on drugs for people with rare diseases.

See Priority review and Marathon Pharmaceuticals

Martin Shkreli

Martin Shkreli (born March 17, 1983) is an American investor and businessman.

See Priority review and Martin Shkreli

Merck & Co.

Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey, and is named for Merck Group, founded in Germany in 1668, of which it was once the American arm.

See Priority review and Merck & Co.

Microsoft

Microsoft Corporation is an American multinational corporation and technology company headquartered in Redmond, Washington.

See Priority review and Microsoft

Miltefosine

Miltefosine, sold under the trade name Impavido among others, is a medication mainly used to treat leishmaniasis and free-living amoeba infections such as Naegleria fowleri and Balamuthia mandrillaris.

See Priority review and Miltefosine

Morquio syndrome

Morquio syndrome, also known as mucopolysaccharidosis type IV (MPS IV), is a rare metabolic disorder in which the body cannot process certain types of sugar molecules called glycosaminoglycans (AKA GAGs, or mucopolysaccharides).

See Priority review and Morquio syndrome

Moxidectin

Moxidectin is an anthelmintic drug used in animals to prevent or control parasitic worms (helminths), such as heartworm and intestinal worms, in dogs, cats, horses, cattle, sheep and wombats.

See Priority review and Moxidectin

Neglected tropical diseases

Neglected tropical diseases (NTDs) are a diverse group of tropical infections that are common in low-income populations in developing regions of Africa, Asia, and the Americas. Priority review and Neglected tropical diseases are tropical diseases.

See Priority review and Neglected tropical diseases

Neurocysticercosis

Neurocysticercosis is a specific form of the infectious parasitic disease cysticercosis that is caused by the infection with Taenia solium, a tapeworm found in pigs.

See Priority review and Neurocysticercosis

New Drug Application

The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Priority review and new Drug Application are Food and Drug Administration.

See Priority review and New Drug Application

Novartis

Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland.

See Priority review and Novartis

Novartis Gene Therapies

Novartis Gene Therapies, until 2020 known as AveXis, is a biotechnology company that develops treatments for rare neurological genetic disorders.

See Priority review and Novartis Gene Therapies

Novimmune

Novimmune is a privately held Swiss pharmaceutical development company focusing on monoclonal antibody therapies for treatment of immune-related diseases.

See Priority review and Novimmune

Nusinersen

Nusinersen, marketed as Spinraza, is a medication used in treating spinal muscular atrophy (SMA), a rare neuromuscular disorder.

See Priority review and Nusinersen

Onasemnogene abeparvovec

Onasemnogene abeparvovec, sold under the brand name Zolgensma, is a gene therapy used to treat spinal muscular atrophy (SMA), a disease causing muscle function loss in children.

See Priority review and Onasemnogene abeparvovec

Onchocerciasis

Onchocerciasis, also known as river blindness, is a disease caused by infection with the parasitic worm Onchocerca volvulus. Priority review and Onchocerciasis are tropical diseases.

See Priority review and Onchocerciasis

Orotic aciduria

Orotic aciduria (AKA hereditary orotic aciduria) is a disease caused by an enzyme deficiency, resulting in a decreased ability to synthesize pyrimidines.

See Priority review and Orotic aciduria

Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. Priority review and Prescription Drug User Fee Act are Food and Drug Administration.

See Priority review and Prescription Drug User Fee Act

Pretomanid

Pretomanid is an antibiotic medication used for the treatment of multi-drug-resistant tuberculosis affecting the lungs.

See Priority review and Pretomanid

Primary hyperoxaluria

Primary hyperoxaluria is a rare condition (autosomal recessive), resulting in increased excretion of oxalate (up to 600 mg a day from normal 50 mg a day), with oxalate stones being common.

See Priority review and Primary hyperoxaluria

Rabies

Rabies is a viral disease that causes encephalitis in humans and other mammals. Priority review and Rabies are tropical diseases.

See Priority review and Rabies

Rare disease

A rare disease is a disease that affects a small percentage of the population.

See Priority review and Rare disease

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York.

See Priority review and Regeneron Pharmaceuticals

RVSV-ZEBOV vaccine

Recombinant vesicular stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV), also known as Ebola Zaire vaccine live and sold under the brand name Ervebo, is an Ebola vaccine for adults that prevents Ebola caused by the Zaire ebolavirus.

See Priority review and RVSV-ZEBOV vaccine

Sanofi

Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France.

See Priority review and Sanofi

Sarepta Therapeutics

Sarepta Therapeutics, Inc. is a medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts, United States.

See Priority review and Sarepta Therapeutics

Schistosomiasis

Schistosomiasis, also known as snail fever, bilharzia, and Katayama fever, is a disease caused by parasitic flatworms called schistosomes. Priority review and Schistosomiasis are tropical diseases.

See Priority review and Schistosomiasis

Sebelipase alfa

Sebelipase alfa, sold under the brand name Kanuma, is a recombinant form of the enzyme lysosomal acid lipase (LAL) that is used as a medication for the treatment of lysosomal acid lipase deficiency (LAL-D).

See Priority review and Sebelipase alfa

Selpercatinib

Selpercatinib, sold under the brand name Retevmo among others, is a medication for the treatment of cancers in people whose tumors have an alteration (mutation or fusion) in a specific gene (RET which is short for "rearranged during transfection").

See Priority review and Selpercatinib

SIGA Technologies

SIGA Technologies, Inc. is an American pharmaceutical company founded in 1995, based in New York City, which develops and sells pharmaceutical solutions for the antiviral treatment of smallpox, monkeypox, cowpox, and vaccinia complications.

See Priority review and SIGA Technologies

Sly syndrome

Sly syndrome, also called mucopolysaccharidosis type VII (MPS-VII), is an autosomal recessive lysosomal storage disease caused by a deficiency of the enzyme β-glucuronidase.

See Priority review and Sly syndrome

Smallpox vaccine

The smallpox vaccine is the first vaccine to have been developed against a contagious disease.

See Priority review and Smallpox vaccine

Spark Therapeutics

Spark Therapeutics, Inc. is a developer of gene therapy treatments, which treat debilitating genetic diseases.

See Priority review and Spark Therapeutics

Tafenoquine

Tafenoquine, sold under the brand name Krintafel among others, is a medication used to prevent and to treat malaria.

See Priority review and Tafenoquine

TB Alliance

TB Alliance (formally The Global Alliance for TB Drug Development) is a not-for-profit product development partnership (PDP) dedicated to the discovery and development of new, faster-acting and affordable tuberculosis (TB) medicines.

See Priority review and TB Alliance

Tecovirimat

Tecovirimat, sold under the brand name Tpoxx among others, is an antiviral medication with activity against orthopoxviruses such as smallpox and mpox.

See Priority review and Tecovirimat

The Wall Street Journal

The Wall Street Journal (WSJ), also referred to simply as the Journal, is an American newspaper based in New York City, with a focus on business and finance.

See Priority review and The Wall Street Journal

Tisagenlecleucel

Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer (adoptive cell transfer).

See Priority review and Tisagenlecleucel

Tom Harkin

Thomas Richard Harkin (born November 19, 1939) is an American lawyer, author, and politician who served as a United States senator from Iowa from 1985 to 2015.

See Priority review and Tom Harkin

Trachoma

Trachoma is an infectious disease caused by bacterium Chlamydia trachomatis. Priority review and trachoma are tropical diseases.

See Priority review and Trachoma

Triclabendazole

Triclabendazole, sold under the brand name Egaten among others, is a medication used to treat fascioliasis and paragonimiasis. It is very effective for both conditions. Treatment in hospital may be required. It is taken by mouth with typically one or two doses being required. Side effects are generally few, but can include abdominal pain and headaches.

See Priority review and Triclabendazole

Tropical disease

Tropical diseases are diseases that are prevalent in or unique to tropical and subtropical regions. Priority review and tropical disease are tropical diseases.

See Priority review and Tropical disease

Tuberculosis

Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is an infectious disease usually caused by Mycobacterium tuberculosis (MTB) bacteria.

See Priority review and Tuberculosis

Ultragenyx

Ultragenyx Pharmaceutical Inc. is an American biopharmaceutical company involved in the research and development of novel products for treatment of rare and ultra-rare genetic diseases for which there are typically no approved treatments and high unmet medical need.

See Priority review and Ultragenyx

References

[1] https://en.wikipedia.org/wiki/Priority_review

Also known as Priority Review Voucher, Priority review (FDA).

, Food and Drug Administration Amendments Act of 2007, Food and Drug Administration Safety and Innovation Act, Golodirsen, GSK plc, GW Pharmaceuticals, Helminthiasis, Ionis Pharmaceuticals, Ivacaftor, Janssen Pharmaceuticals, Kite Pharma, Knight Therapeutics, Lassa fever, Leadiant Biosciences, Leishmaniasis, Lennox–Gastaut syndrome, Leprosy, Lumasiran, Lymphatic filariasis, Malaria, Marathon Pharmaceuticals, Martin Shkreli, Merck & Co., Microsoft, Miltefosine, Morquio syndrome, Moxidectin, Neglected tropical diseases, Neurocysticercosis, New Drug Application, Novartis, Novartis Gene Therapies, Novimmune, Nusinersen, Onasemnogene abeparvovec, Onchocerciasis, Orotic aciduria, Prescription Drug User Fee Act, Pretomanid, Primary hyperoxaluria, Rabies, Rare disease, Regeneron Pharmaceuticals, RVSV-ZEBOV vaccine, Sanofi, Sarepta Therapeutics, Schistosomiasis, Sebelipase alfa, Selpercatinib, SIGA Technologies, Sly syndrome, Smallpox vaccine, Spark Therapeutics, Tafenoquine, TB Alliance, Tecovirimat, The Wall Street Journal, Tisagenlecleucel, Tom Harkin, Trachoma, Triclabendazole, Tropical disease, Tuberculosis, Ultragenyx, United Therapeutics, Uridine triacetate, Vertex Pharmaceuticals, Vestronidase alfa, Voretigene neparvovec, X-linked hypophosphatemia, Yaws, Zellweger syndrome, Zika virus.

Priority review, the Glossary

Table of Contents

See also

Pharmaceutical regulation in the United States

References