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Management: Food and Drug Administration (FDA)
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Total 621 results found since Jan 2013.
Janssen Demonstrates Commitment to Advancing Science and Innovation in the Treatment of Solid Tumors at ESMO Annual Congress
September 8, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than ten data presentations from its lung cancer, bladder cancer and prostate cancer portfolio and pipeline will be featured during the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting, September 16–21. Further details about these data and the science Janssen is advancing will be made available throughout ESMO via the Janssen Oncology Virtual Newsroom.“With a diverse oncology portfolio and pipeline spanning bladder cancer, lung cancer and prostate cancer, Janssen...
Source: Johnson and Johnson - September 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
The Current Role of Clevidipine in the Management of Hypertension
AbstractAcute hypertension, which may damage blood vessels, causes irreversible organ damage to the vasculature, central nervous system, kidney, and heart. Clevidipine, the first third-generation calcium channel antagonist approved by the Food and Drug Administration (FDA) in the past 20 years, is an ultra-short-acting calcium channel blocker that inhibits L-type calcium channels with high clearance and low distribution, can be rapidly metabolized into the corresponding inactive acid, and is rapidly hydrolyzed into inactive metabolites by esterase in arterial blood. Clevidipine is the same as nicardipine in that the main p...
Source: American Journal of Cardiovascular Drugs - September 2, 2021 Category: Cardiology Source Type: research
Janssen Announces U.S. FDA Approval of INVEGA HAFYERA ™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J., Sept. 1, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. Before transitioning to INVEGA HAFYERA™, patients must be adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA® (3-month paliperidone palmitate) for at least one 3-month injection cycle.1 The FDA approval of INVEGA ...
Source: Johnson and Johnson - September 1, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
FDA Approves First Nerve-Stimulation Device to Aid Stroke Recovery
FRIDAY, Aug. 27, 2021 -- A first-of-its-kind nerve stimulation treatment for people who have difficulty moving their arms after a stroke has been approved by the U.S. Food and Drug Administration.
The Vivistim System is a prescription therapy for...
Source: Drugs.com - Pharma News - August 27, 2021 Category: Pharmaceuticals Source Type: news
FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab FDA OKs First Vagus Nerve Stimulation System for Stroke Rehab
The US Food and Drug Administration has approved a first-of-its kind vagus nerve stimulation system to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke.FDA Approvals
Source: Medscape Neurology and Neurosurgery Headlines - August 27, 2021 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news
FDA Approves First Nerve-Stimulation Device to Aid Stroke Recovery
FRIDAY, Aug. 27, 2021 -- A first-of-a-kind nerve stimulation treatment for people who have problems moving their arms after a stroke has been approved by the U.S. Food and Drug Administration. " People who have lost mobility in their hands and arms...
Source: Drugs.com - Daily MedNews - August 27, 2021 Category: General Medicine Source Type: news
FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS
Circulation. 2021 Aug 24;144(8):655-658. doi: 10.1161/CIRCULATIONAHA.120.053294. Epub 2021 Aug 23.NO ABSTRACTPMID:34424771 | DOI:10.1161/CIRCULATIONAHA.120.053294
Source: Circulation - August 23, 2021 Category: Cardiology Authors: Leila G Lackey Christine E Garnett Fred Senatore Source Type: research
O-005 Comparison of on-label versus off-label treatment of intracranial aneurysms with the pipeline embolization devices
ConclusionIn real-world practice, off-label uses of PED can achieve similar safety and efficacy to on-label uses, though there may be a slightly higher rate of ischemic complications in off-label uses. Expert judgment is a useful supplement to official guidelines when assessing reasonable PED use beyond its approved indications.Disclosures S. Cler: None. D. Lauzier: None. A. Kansagra: 2; C; Penumbra, Microvention, iSchemaView.
Source: Journal of NeuroInterventional Surgery - July 26, 2021 Category: Neurosurgery Authors: Cler, S., Lauzier, D., Kansagra, A. Tags: Oral abstracts Source Type: research
Revealing new therapeutic opportunities in hypertension through network-driven integrative genetic analysis and drug target prediction approach
Gene. 2021 Jul 19:145856. doi: 10.1016/j.gene.2021.145856. Online ahead of print.ABSTRACTEpidemiological studies have established that untreated hypertension (HTN) is a major independent risk factor for developing cardiovascular diseases (CVD), stroke, renal failure, and other conditions. Several important studies have been published to prevent and manage HTN; however, antihypertensive agents' optimal choice remains controversial. Therefore, the present study is undertaken to update our knowledge in the primary treatment of HTN, specifically in the setting of other three important diseases. MicroRNAs (miRNAs) are remarkabl...
Source: Gene - July 22, 2021 Category: Genetics & Stem Cells Authors: Kavita Sharma Prithvi Singh Md Amjad Beg Ravins Dohare Fareeda Athar Mansoor Ali Syed Source Type: research
