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16:30 New photos show mother right after giving birth in car, says it was 'perfect'

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  • FDA issues recall on J&J heart device

    January 2, 2018 7:11 PM 35

    (Reuters) - The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve. The valve, which prevents blood from flowing back through it, is part of a device used to insert and position cardiovascular catheters in the heart. (bit.ly/2A7nOIj) About 110 Agilis Steerable Introducer

  • Flu outbreak already reported in 36 states, CDC says

    December 29, 2017 7:53 PM 171

    In the last week of the year, 21 states experienced high influenza activity and other five qualified in the moderate range. (Kurhan) As many as 36 states across the U.S. have reported widespread influenza activity already, but epidemiologists say it is too soon to say how bad the flu season will be this year. The early start of the outbreaks, which usually

  • FDA approves Mylan's copy of Allergan's vaginal cream

    December 29, 2017 5:33 PM 30

    (Reuters) - Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allergan’s Estrace cream for vaginal atrophy. The approval comes amid the FDA’s efforts to speed to market generic versions of complex drugs such as Mylan’s own EpiPen, an emergency allergy shot. Complex drugs include medicines like metered-dose

  • The Latest: Praise, contempt for Down syndrome abortion law

    December 22, 2017 7:19 PM 29

    An anti-abortion group says a new Ohio law banning doctors from performing abortions based on diagnoses of Down syndrome will give unborn babies with the genetic disorder "a shot at life." But abortion rights groups argue the law will be another blow to women's constitutional right to legal abortion. Republican Gov. John Kasich (KAY'-sihk) signed the legislation

  • Novartis combo therapy for melanoma gets FDA priority review

    December 22, 2017 6:41 AM 37

    ZURICH (Reuters) - The U.S. Food and Drug Administration has granted priority review for Novartis’s Tafinlar in combination with Mekinist for treating some patients with advanced melanoma, the Swiss drugmaker said on Friday. The review covers the combination therapy for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations

  • FDA approves La Jolla's low blood pressure drug

    December 21, 2017 11:37 PM 37

    (Reuters) - La Jolla Pharmaceutical said on Thursday the U.S. Food and Drug Administration had approved its drug, Giapreza, to treat dangerously low blood pressure. The company said it plans to make Giapreza available for patients in the United States in March. La Jolla’s shares rose 4.2 percent to $32.45 in extended trading on Thursday. The injectable

  • Second U.S. judge blocks Trump administration birth control rules

    December 21, 2017 7:45 PM 33

    SAN FRANCISCO (Reuters) - A second U.S. judge blocked President Donald Trump’s administration from enforcing new rules that undermine an Obamacare requirement for employers to provide insurance that covers women’s birth control. U.S. District Judge Haywood Gilliam in Oakland, California, on Thursday said the federal government likely did not follow proper

  • Canada's Aeterna gets FDA approval for growth hormone deficiency test

    December 20, 2017 10:49 PM 35

    (Reuters) - Canada’s Aeterna Zentaris Inc said on Wednesday the U.S. Food and Drug Administration has approved its oral test to diagnose adult growth hormone deficiency. The company said it intends to launch the test, Macrilen, in the United States during the first quarter of 2018. Macrilen stimulates the secretion of growth hormone, which is then measured

  • South Korea's Samsung Bioepis says FDA to review Herceptin copy

    December 20, 2017 12:22 AM 37

    SEOUL (Reuters) - South Korea’s Samsung Bioepis Co Ltd said on Wednesday the U.S. Food and Drug Administration (FDA) has accepted for review its copy of Swiss drugmaker Roche’s blockbuster breast cancer drug Herceptin for potential approval. Samsung Bioepis said in a statement that if approved, its version of Herceptin will be commercialized in the United

  • Tennessee woman gives birth to baby who was frozen as embryo for 24 years

    December 19, 2017 6:48 PM 221

    Baby Emma Wren was born in November after being frozen in an embryo for 24 years. (Benjamin and Tina Gibson ) A Tennessee woman gave birth to a baby who had been frozen as an embryo for more than 24 years — the longest known frozen human embryo to come to birth. The National Embryo Donation Center (NEDC) announced Tuesday that Emma Wren was born on Nov. 25 to Tina Gibson