Guideline Med Alerts & FDA Approvals – December 2024
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Upcoming FDA Decisions – January 2025
The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]
Read MoreAlirocumab (Praluent/Regeneron) – Guidelines+ Monographs
In this edition of the Guidelines+ Monographs Series will delve into the medication alirocumab, marketed under the brand name Praluent® from Regeneron. Praluent (alirocumab) is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease, as […]
Read MoreIrinotecan Liposome Injection (Onivide/Ipsen) – Guidelines+ Monographs
Our latest edition of the Guidelines+ Monographs Series will delve into the medication irinotecan liposome injection, marketed under the brand name Onivyde® by Ipsen. Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan used in the treatment of pancreatic adenocarcinoma. Onivyde is indicated in combination with oxaliplatin, fluorouracil and leucovorin, […]
Read MoreBaloxavir Marboxil (Xofluza/Genetech) – Guidelines+ Monographs
In recognition of National Influenza Vaccination Week (NIVW), our latest edition of the Guidelines+ Monographs Series will delve into the medication baloxavir marboxil, marketed under the brand name Xofluza® by Genentech. Xofluza is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients 5 years of age […]
Read MoreBictegravir, Emtricitabine, and Tenofovir Alafenamide (Biktarvy/Gilead ) – Guidelines+ Monographs
In recognition of World AIDS Day 2024, our latest edition of the Guidelines+ Monographs Series will delve into the medication bictegravir, emtricitabine, and tenofovir alafenamide, marketed under the brand name Biktarvy® by Gilead Sciences, Inc. Biktarvy is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), […]
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Guideline Med Alerts & FDA Approvals – November 2024
Sign up for alerts and stay informed on the latest published guidelines, FDA decisions, and more! Copyright © 2024 Guideline Central, All Rights Reserved.
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Upcoming FDA Decisions – December 2024
The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug […]
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Epilepsy – What’s Changed
Each November, we commemorate National Epilepsy Awareness Month (NEAM), focusing on educating the public about epilepsy symptoms and supporting research efforts. In honor of NEAM, today’s article will focus on epilepsy. According to the Centers for Disease Control (CDC), between 2021 and 2022, approximately 2.9 million adults aged 18 and older reported experiencing active epilepsy, […]
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Dravet Syndrome Guidelines – What’s Changed
Dravet syndrome is a rare form of epilepsy that typically manifests in infancy or early childhood. According to the National Institutes of Health (NIH), initial symptoms often present as either focal or generalized convulsive seizures that begin before the age of 15 months, with many cases occurring before the age of one. These initial seizures […]
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