Novel Reversal Agent for Ticagrelor Gets FDA’s Breakthrough Therapy Designation
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PB2452 (PhaseBio), an investigational reversal agent for ticagrelor.
All articles by Diana Ernst, RPh
FDA Updates REMS for Transmucosal Immediate-Release Fentanyl Products
The Food and Drug Administration has announced that the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medications has been updated to better ensure the safe use of these products.
FDA Approves New Valsartan Product Following Major Recall
The Food and Drug Administration (FDA) has approved a new generic version of Diovan (Novartis) that does not contain N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), 2 potentially carcinogenic impurities identified in several recalled valsartan products.
Health Experts Review 41 Diets, Rank Best Overall for 2019
The popular Keto diet, which focuses on strict carbohydrate limitations and high-fat intake, was ranked at #38.
AGS: Beers Criteria for Potentially Inappropriate Med Use in Older Adults Updated
Over 1400 clinical trials and research studies were reviewed by a panel of 13 experts to develop the new guideline.
New Treatment Option for Serious Fungal Infections Now Available
Tolsura, which contains the azole antifungal itraconazole, is formulated using the Company’s proprietary SUBA (SUper-BioAvailable) technology which improves the bioavailability of poorly soluble drugs.
FDA Clears Elevo Kit Snoring Intervention Device
The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients.
CDC: Top 10 Drugs Involved in Drug Overdose Deaths
Using data from the 2011 to 2016 National Vital Statistics System-Mortality files, the authors conducted a literal text analysis of death certificates to identify drugs mentioned as contributing to the cause of overdose death.
FDA Grants Orphan Drug Designation to Huntington Disease Treatment
In animal studies, the treatment was associated with improvement in both motor and cognitive function.
New Tablet Strength of Sickle Cell Anemia Treatment Siklos Available
In addition to the 1000mg tablet, Siklos is also available in 100mg tablets.
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