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Timely Insights for Healthcare Experts 

FDA Approves New Treatment for HSDD in Premenopausal Women

FDA approves bremelanotide  (Vyleesi, AMAG Pharmaceuticals) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Bremelanotide is the first-in-class melanocortin 4 receptor agonist for HSDD, and joins Flibanserin as...

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First P13K inhibitor for Breast Cancer Gets FDA Approved

Pigray (alpelisib) tablets have been FDA approved to treat breast cancer in combination with FDA-approved endocrine therapy fulvestrant. Pigray is approved for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...

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Novel FDA Drug Approvals: February-May 2019

Every year, the US FDA’s Center for Drug Evaluation and Research (CDER) releases a list of newly-approved novel drugs and therapeutic biological products. Last year's Novel Drug Approvals list holds the record for the most number of approved drugs, effectively...

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Breakthrough Non-Drug ADHD Treatment Gets FDA Approval

Children living with attention hyperactivity disorder (ADHD) may soon experience non-pharmacologic relief through a breakthrough medical device. For children between the ages 7 and 12 and currently not on medication, the pocket-sized device works by delivering mild...

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CDC Update: E. Coli O103 Outbreak Is from Ground Beef

Update to PEPID Pulse “E. Coli O103 Outbreak Investigation in Five States” on April 5 , 2019 The CDC has narrowed the Shiga Toxin-producing Escherichia Coli (E. Coli) O103 outbreak to ground beef.  The total number of people infected has increased to 109 people...

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E. Coli O103 Outbreak Investigation in Five States

The CDC, several states, the U.S. Department of Agriculture’s Food Safety and Inspection Services, and the U.S. FDA are investigating a multistate outbreak of Shiga Toxin-producing Escherichia coli (E.Coli) O103 infections. There is not yet an identification of a...

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Cerner Endorses Adoption of Normative FHIR R4 Standard

Kansas-based EHR vendor Cerner proudly takes the industry lead in adopting HL7's latest rollout - FHIR Release 4, the normative interoperability standard. The vendor embraced FHIR R4 only 3 months after it was published. “It’s incredibly important that major vendors...

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FDA Approves Two New Oral Drugs to Treat Multiple Sclerosis

Mayzent (siponimod) The FDA approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Mayzent was shown to be...

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