Results 281 to 290 of about 776,039 (330)
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The American Journal of Medicine, 2020
In 2019, the US Food and Drug Administration (FDA) approved 48 novel drugs. Thirty of the 48 (62.5%) novel drug approvals were reviewed and approved through an expedited review pathway while 20 of the 48 (41.7%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2019.
Alex M. Ebied +2 more
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In 2019, the US Food and Drug Administration (FDA) approved 48 novel drugs. Thirty of the 48 (62.5%) novel drug approvals were reviewed and approved through an expedited review pathway while 20 of the 48 (41.7%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2019.
Alex M. Ebied +2 more
openaire +3 more sources
Science, 2005
We are concerned about misinformation in the News Focus article “Lupus drug company asks FDA for second chance” (J. Couzin, 11 Feb., p. [835][1]). It is not true that the U.S. Food and Drug Administration (FDA) has rejected the medication LJP 394, which is under active development by La Jolla Pharmaceutical Company.
Joan T. Merrill, Sandra Raymond
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We are concerned about misinformation in the News Focus article “Lupus drug company asks FDA for second chance” (J. Couzin, 11 Feb., p. [835][1]). It is not true that the U.S. Food and Drug Administration (FDA) has rejected the medication LJP 394, which is under active development by La Jolla Pharmaceutical Company.
Joan T. Merrill, Sandra Raymond
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Drug Information Journal, 1992
The Passport to Drug Approval in Europe will be changed in the future. The proposal of the Commission of the European Economic Community (EC) for the free movement of medicinal products in the future is discussed. After a short discussion of the proposal, information is given on the influence outside the EC, on what happens in the EC, and the influence
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The Passport to Drug Approval in Europe will be changed in the future. The proposal of the Commission of the European Economic Community (EC) for the free movement of medicinal products in the future is discussed. After a short discussion of the proposal, information is given on the influence outside the EC, on what happens in the EC, and the influence
openaire +2 more sources
Nature Reviews Drug Discovery, 2010
In a year in which regulators and drug companies gained familiarity with risk management strategies, the number of new drug approvals was similar to that in 2008.
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In a year in which regulators and drug companies gained familiarity with risk management strategies, the number of new drug approvals was similar to that in 2008.
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T-PA and the Principles of Drug Approval
New England Journal of Medicine, 1987The recent approval by the Food and Drug Administration of tissue plasminogen activator (t-PA) for clot lysis and preservation of myocardial function in patients with acute myocardial infarction ha...
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Accelerating drug development and approval
Drug News & Perspectives, 2010Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority ...
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Tardive Dyskinesia Drug Approved
JAMA, 2017The first drug for adults with tardive dyskinesia (TD) has received FDA approval. Tardive dyskinesia is a neurological disorder that causes repetitive, involuntary movements such as abnormal tongue and lip movements, cheek bulging, foot tapping, shoulder shrugging, and rocking and swaying movements.
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Non-Approved Use of Food and Drug Administration Approved Drugs
American Journal of Ophthalmology, 1979Joseph I. Goldstein, Joel S. Mindel
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