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FDA Approves Lybalvi
2021-06-01 Mark Gualtieri Health News

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, June 1, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS)

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FDA Approves Empaveli
2021-05-17 Mark Gualtieri Health News

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a

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The FDA Seeks a New Way to Review Old Drugs Without Causing Prices to Soar
2021-04-15 Mark Gualtieri Health News

Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine. Doctors have used the drug

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FDA Urges Pause of J&J COVID Vaccine
2021-04-13 Mark Gualtieri Health News

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The FDA and CDC has recommended that use of the Johnson &

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FDA approves 2 rapid coronavirus tests to be sold over-the-counter for at-home use
2021-04-03 Mark Gualtieri Health News

Fox News Flash top headlines for April 2 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and

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Class I Recall Issued for Some Affinity Pixie Oxygenators
2021-03-25 Mark Gualtieri Health News

Medtronic is recalling some Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface devices and Perfusion Tubing Packs because of potentially elevated levels of

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Companies Seek EUA for New COVID Monoclonal Antibody Treatment
2021-03-11 Mark Gualtieri Health News

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. An independent data monitoring committee is recommending stopping enrollment of a

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Abbott’s Test to Distinguish Coronavirus and Flu Viruses Gets US Authorization
2021-03-08 Mark Gualtieri Health News

(Reuters) – Abbott Laboratories said on Friday that the U.S. Food and Drug Administration granted emergency use authorization for its molecular test to detect and

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Variants Spur New FDA Guidance on COVID Vaccines, Tests, Drugs
2021-02-23 Mark Gualtieri Health News

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center. The US Food and Drug Administration (FDA) on Monday updated its

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Diverticulitis: A New Standard of Care?
2021-02-22 Mark Gualtieri Health News

Outpatient treatment of diverticulitis with amoxicillin-clavulanate is as effective as treatment with metronidazole plus a fluoroquinolone, according to a study published online February 22 in

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