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New Migraine Drug Gains Approval

New Migraine Drug Gains Approval News & Analysis News From the Food and Drug Administration Another Targeted Therapy toms including cough, dyspnea, fever, and Billy Dunn, MD, acting director of the Of- for ERBB2-Positive Breast Cancer other respiratory symptoms. fice of Neuroscience at the FDA, noted in a The FDA recently granted accelerated statement that disabling migraines affect an approval to an antibody-drug combination estimated 37 million people in the United for adults who’ve already received at least 2 Asmall-moleculedrugthatblockspaintrans- States. “The FDA…will continue to work with treatment regimens for unresectable or missioninthetrigeminovascularsystemisthe stakeholders to promote the development metastatic breast cancer that is positive for of new safe and effective migraine thera- first in its class to be approved for adults who human epidermal growth factor receptor 2 havemigraineheadacheswithorwithoutaura. pies,” he added. (ERBB2; formerly HER2/neu). Adverse events reported in the trials in- Marketed as Enhertu, fam-trastuzumab cluded nausea, dizziness, and sleepiness. deruxtecan-nxki is an anti-ERBB2 antibody withacytotoxictopoisomeraseIinhibitorat- FDA’s New Effort to Improve tached. It is administered via intravenous in- Compounded Drug Quality Inspections of compounding facilities in re- fusion. According to the FDA, about 20% of breast cancers have a genetic mutation that cent years that have turned up unsanitary conditions and prompted some http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

New Migraine Drug Gains Approval

Voelker, Rebecca
JAMA , Volume 323 (5) – Feb 4, 2020
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New Migraine Drug Gains Approval

Abstract

News & Analysis News From the Food and Drug Administration Another Targeted Therapy toms including cough, dyspnea, fever, and Billy Dunn, MD, acting director of the Of- for ERBB2-Positive Breast Cancer other respiratory symptoms. fice of Neuroscience at the FDA, noted in a The FDA recently granted accelerated statement that disabling migraines affect an approval to an antibody-drug combination estimated 37 million people in the United for adults who’ve already received at least 2...
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Publisher
American Medical Association
Copyright
Copyright 2020 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2020.0081
Publisher site
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Abstract

News & Analysis News From the Food and Drug Administration Another Targeted Therapy toms including cough, dyspnea, fever, and Billy Dunn, MD, acting director of the Of- for ERBB2-Positive Breast Cancer other respiratory symptoms. fice of Neuroscience at the FDA, noted in a The FDA recently granted accelerated statement that disabling migraines affect an approval to an antibody-drug combination estimated 37 million people in the United for adults who’ve already received at least 2 Asmall-moleculedrugthatblockspaintrans- States. “The FDA…will continue to work with treatment regimens for unresectable or missioninthetrigeminovascularsystemisthe stakeholders to promote the development metastatic breast cancer that is positive for of new safe and effective migraine thera- first in its class to be approved for adults who human epidermal growth factor receptor 2 havemigraineheadacheswithorwithoutaura. pies,” he added. (ERBB2; formerly HER2/neu). Adverse events reported in the trials in- Marketed as Enhertu, fam-trastuzumab cluded nausea, dizziness, and sleepiness. deruxtecan-nxki is an anti-ERBB2 antibody withacytotoxictopoisomeraseIinhibitorat- FDA’s New Effort to Improve tached. It is administered via intravenous in- Compounded Drug Quality Inspections of compounding facilities in re- fusion. According to the FDA, about 20% of breast cancers have a genetic mutation that cent years that have turned up unsanitary conditions and prompted some

Journal

JAMA – American Medical Association

Published: Feb 4, 2020

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