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721 Articles Matching "approves"

UnitedHealth Reverses Course, Approves Coverage For $2.1 Million Gene Therapy For Family Racing Against Clock

Jul 20, 2019 , Kaiser Health News
Lauren Sullivan had been trying to appeal UnitedHealth's initial refusal of the drug for her 21-month-old daughter, Daryn. The girl was running out of time to receive the treatment before her second birthday in October, when the drug has to be administered. The company also approved claims for three other patients. In other news, UnitedHealth beats expectations for the quarter, prompting company to boost earnings...
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FDA Approves New Libido-Boosting Drug for Premenopausal Women

Jul 03, 2019 , RxList
The US Food and Drug Administration (FDA) today approved bremelanotide (Vyleesi, AMAG Pharmaceuticals), a first-in-class melanocortin 4 receptor agonist for hypoactive sexual desire disorder (HSDD) in premenopausal...
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FDA Approves New Libido-Boosting Drug for Women

Jul 03, 2019 , eMedicine Health
FDA Approves New Libido-Boosting Drug for Premenopausal...
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FDA approves new indication for Lilly’s Emgality

Jun 06, 2019 , Drug Store News - Retail
Emgality is the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache. Read More...
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FDA Approves First Drug to Help Tame Cluster Headaches

Jun 06, 2019 , MedicineNet
Title: FDA Approves First Drug to Help Tame Cluster HeadachesCategory: Health NewsCreated: 6/5/2019 12:00:00 AMLast Editorial Review: 6/5/2019 12:00:00...
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FDA Approves First PI3K Inhibitor for Breast Cancer

Jun 05, 2019 , RxList
Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based...
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FDA OKs First PI3K Inhibitor for Breast Cancer

Jun 05, 2019 , eMedicine Health
FDA Approves First PI3K Inhibitor for Breast...
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FDA approves Lilly's migraine drug as first ever cluster headache treatment

Jun 05, 2019 , Reuters
Eli Lilly and Co's migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks, the Food and Drug Administration said...
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FDA Makes New Cancer Treatments Easier to Get

Jun 04, 2019 , WebMD
Rather than making doctors beg for these drugs, if the company approves, the FDA will intercede and help the process along, the agency announced at the meeting of the American Society of Clinical Oncology in...
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Merck wins U.S. FDA approval for expanded use of antibiotic

Jun 04, 2019 , Reuters
The U.S. Food and Drug Administration said -events/press-announcements/fda-approves-new-treatment-hospital-acquired-and-ventilator-associated-bacterial-pneumonia on Monday it approved expanded use of Merck & Co Inc's antibiotic to treat hospital-acquired pneumonia in patients 18 years and older....
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FDA Approves First Test for Zika in Human Blood

May 31, 2019 , MedicineNet
Title: FDA Approves First Test for Zika in Human BloodCategory: Health NewsCreated: 5/30/2019 12:00:00 AMLast Editorial Review: 5/30/2019 12:00:00...
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FDA Approves First Gene Therapy for Spinal Muscular Atrophy

May 30, 2019 , MedicineNet
Title: FDA Approves First Gene Therapy for Spinal Muscular AtrophyCategory: Health NewsCreated: 5/28/2019 12:00:00 AMLast Editorial Review: 5/29/2019 12:00:00...
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FDA Approves Most Expensive Medicine in U.S. History

May 29, 2019 , MedicineNet
Title: FDA Approves Most Expensive Medicine in U.S. HistoryCategory: Health NewsCreated: 5/28/2019 12:00:00 AMLast Editorial Review: 5/28/2019 12:00:00...
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FDA approves Novartis' $2.1 million gene therapy — making it the world's most expensive drug

May 25, 2019 , CNBC Health
The therapy, Zolgensma, is a one-time treatment for spinal muscular atrophy — a muscle-wasting disease and leading genetic cause of infant mortality, affecting 1 in every 11,000 live...
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Health Canada approves Apple Watch ECG, public health groups warn of tobacco's guerrilla social media ads and more digital health news briefs

May 23, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
Also: HoloLens may affect surgeon's precision dexterity; Backpack Health integrates...
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Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia

May 17, 2019 , Reuters
Roche said on Thursday that the U.S. Food and Drug Administration had approved a treatment using its drugs Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia....
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Tennessee To Seek Controversial Medicaid Block Grant Waiver In Move That Will Test How Far CMS Is Willing To Go

May 07, 2019 , Kaiser Health News
The Trump administration has been studying whether it legally can allow states this leeway, and Democratic lawmakers have vowed to fight block grants if CMS approves them. Critics say that shifting to block grants would leave states with little option other than to slash Medicaid enrollment and benefits. News on Medicaid comes out of Kansas and Iowa, as well....
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FDA Approves New Cigarette Alternative From Philip Morris With Restrictions On How It Can Be Marketed

May 02, 2019 , Kaiser Health News
The FDA said it considers IQOS, which heats tobacco without burning it, to be a type of cigarette. Public health experts were disappointed with the decision from the agency that had been taking aggressive steps toward cracking down on smoking and vaping....
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CMS approves Livongo as enrolled provider for Medicare Advantage

May 01, 2019 dave.muoio@himssmedia.com (Dave Muoio), Mobile Health News
In addition, the company's diabetes management program will soon be available to qualifying Cambia Health Solution...
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FDA approves expanded label for Regeneron/Sanofi's cholesterol drug

Apr 27, 2019 , Reuters
The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc's cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events....
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