Food And Drug Administration

Manufacturer Halts Distribution Of Generic Zantac After Cancer-causing Impurity Discovery

When the FDA issued a bulletin alerting everyone to the presence of a possible cancer-causing impurity in the popular heartburn drug marketed as Zantac, the administration stopped short of telling people to stop taking the popular drugs. Now, in the...
Related topics: Cancer, Oncology, Medical Research

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Zimmer Biomet's New Juggerstitch To Grow Sports Medicine Line

Zimmer Biomet Holdings, Inc. ZBH recently received the FDA’s 510(k) clearance for its meniscal repair device JuggerStitch. This next-generation machine will now be commercially available in the market and help broaden the company’s...

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Roche's Gazyva Now A Breakthrough Therapy For Lupus Nephritis

Roche RHHBY announced that the FDA has granted Breakthrough Therapy designation (BTD) to its lymphoma drug Gazyva (obinutuzumab) for a new indication.The agency granted BTD to the drug based on data from the phase II NOBILITY study in adult patients...
Related topics: Lupus, Lymphoma, Medical Research

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Merck's Keytruda Combo Gets Fda Nod For Endometrial Carcinoma

Merck & Co., Inc. MRK announced that its blockbuster drug, Keytruda, in combination with Lenvima, received accelerated approval from the FDA as a treatment for advanced endometrial carcinoma.Women with advanced endometrial carcinoma in whom...
Related topics: Merck & Co

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Does The Fda Even Regulate E-cigs? Actually Kinda Not

That’s why all those weird, possibly toxic flavorings are allowed—and the lax regulatory environment goes back a century.

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How A Vaping Ban Would Affect Big Tobacco

In this episode of MarketFoolery, host Chris Hill chats with Foolish analysts Bill Mann and Bill Barker about some market news. Altria (NYSE: MO) popped on the FDA's proposed flavored e-cig ban. But it's not entirely good news for the giant tobacco...
Related topics: Smoking, Altria Group (MO)

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La Fda Autoriza Instalaciones De Mayo Clinic Para Imagenes De Deteccion Oncologica Avanzada

La Administracion de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en ingles) autorizo el uso de las instalaciones radiofarmacologicas con tomografia por emision de positrones, tambien conocidas como instalaciones del ciclotron, en...
Related topics: Mayo Clinic

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Fda Awards Anabios Grant To Further Develop Preclinical Assay Using Human Primary Cardiomyocytes

The U.S. Food and Drug Administration (FDA) has named AnaBios the recipient of a grant to further develop its unique drug discovery platform utilizing muscle cells from the human heart (cardiomyocytes).
Related topics: Medical Research

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Could Vaping Concerns Boost The Chances Of U.s. Pot Legalization?

If you've kept up with the national news lately, you're no doubt aware of significant health issues that have been linked to vaping. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), along with...
Related topics: Centers For Disease Control And Prevention

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Another Popular Heartburn Drug Gets Fda Cancer Warning

Since last year, the FDA has been looking into the presence of impurities in various types of medication, leading to multiple drug recalls over past months. In the latest announcement on this matter, the agency reports that some units of a popular...
Related topics: Cancer, Oncology

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Will Renal Denervation For Hypertension Rise Again?

'There's once again excitement about renal artery denervation and…it's justified,' says one cardiologist, while another hopes for FDA approval next year, and a third is 'still not 100% convinced.' theheart.org on Medscape
Related topics: Hypertension, Cardiology

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Good News, Bad News In The War On Peanut Allergy

Aimmune shares dipped on Monday after the FDA's Allergenic Products Advisory Committee voted to support the use of AR101 (Palforzia) in children and teens with peanut allergy.
Related topics: Allergies

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Fda Panel Backs First-in-class Medication For Peanut Allergy

An FDA advisory panel recommended peanut allergen powder (Palforzia, Aimmune Therapeutics) for children aged 4 years through 17 years who are allergic to peanuts. Medscape Medical News
Related topics: Allergies, Allergens

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There’s A Reason We Don’t Know Much About Ai

Last year, when the Food and Drug Administration approved an Apple Watch feature that notified users if they had an irregular heart rhythm, the information tech industry hailed it as a watershed moment in consumer-focused health care. Cardiologists,...
Related topics: Cardiology

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Fda: Novel Breast Ca Drugs Linked To Severe Lung Illness

(MedPage Today) -- Reports of ILD, pneumonitis in patients on CDK4/6 inhibitors

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Federal “right-to-try” Over A Year Later: Still A Failure And Still About The Money (and...

Federal "right-to-try" legislation was passed and signed into law by President Trump over a year ago. Advocates promised that lots of terminally ill people who were dying then would be saved by having the right to "try" experimental therapies...

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Fda: Nitrosamines Found In New Class Of Meds

(MedPage Today) -- Popular OTC and prescription antacid hit with contamination

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Fda Panel Backs Oral Immunotherapy For Peanut Allergy

(MedPage Today) -- Approval likely to entail REMS requiring that patients carry epinephrine injectors
Related topics: Allergies

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Could Fda E-cigarette Regulations Help More People Quit Smoking?

Michael P. Eriksen Health, Americas A sales clerk exhales vapor while smoking with a vaporizer during a wait for customers at the e-cigarette shop Henley Vaporium in New York. E-cigarettes are smoking hot. They are the most popular...
Related topics: Smoking, Nicotine

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Fda Finds Traces Of Potential Carcinogen In Popular Heartburn Medications

The chemical was detected in certain ranitidine medicines like Zantac, which are commonly used to treat ulcers and indigestion.
Related topics: Cancer

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