Food And Drug Administration

After Fda Approval, Hopes For The 1st Postpartum Depression Treatment

The FDA approved the first-ever treatment for postpartum depression. NPR's Michel Martin speaks with writer Teresa Wong about her own experiences with postpartum depression.
Related topics: Depression

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Fda: Higher Risk For Death Found With Venclexta In Multiple Myeloma

FRIDAY, March 22, 2019 -- A safety statement was issued yesterday by the U.S. Food and Drug Administration regarding risks found to be associated with the investigational use of Venclexta (venetoclax) for treatment of patients with multiple...

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Fda Approves Ketamine Derivative As Depression Treatment For First Time

Treatment-resistant depression affects 1 in 3 of the estimated 16.2 million adults in the U.S. who have suffered at least one major depressive episode. For them, two or more therapies have failed and the risk of suicide is much greater. It’s a...
Related topics: Depression

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Magnetic Device For Alzheimer's Nixed By Fda Advisors

(MedPage Today) -- But "there's probably a signal here," panelists say
Related topics: Alzheimer's Disease

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Group Calls For Moratorium On Fda Opioid Approvals

(MedPage Today) -- FDA advisory committee chairman also supports Public Citizen's petition
Related topics: Petitions

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Will More Genetically Engineered Foods Be Approved Under The Fda's New Leadership?

The world of food and drug regulation was rocked earlier this month by the news of a change in leadership at the Food and Drug Administration. Commissioner Scott Gottlieb resigned and will step down in early April. His temporary replacement is Dr....
Related topics: Genetics

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Fda Tiered Approval

Jacob J. Gottlieb and Joseph Gulfo have an interesting op-ed on a tiered approval regime for the FDA: Instituting a codified approval paradigm based on four tiered levels of clinical effectiveness (biomarkers, clinical signs and symptoms, disease...

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Fda Approves First Drug For Postpartum Depression, Zulresso (brexanolone)

WEDNESDAY, March 20, 2019 -- Postpartum depression is a common and often devastating condition for new mothers, but the U.S. Food and Drug Administration on Tuesday approved the first drug to help combat it. The drug, Zulresso (brexanolone), is...
Related topics: Depression

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Will More Genetically Engineered Foods Be Approved Under The Fda’s New Leadership?

The world of food and drug regulation was rocked earlier this month by the news of a change in leadership at the Food and Drug Administration. Commissioner Scott Gottlieb resigned and will step down in early April. His temporary replacement is Dr....
Related topics: Genetics

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Fda Creates A Game That Will Help Kids To Stop Smoking

We all know that smoking is bad for your health and that kids smoking is also another issue. However the FDA thinks that they might have the answer to stop kids from smoking and that is through the creation of a PC and Xbox One game dubbed...
Related topics: Smoking

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Fda Takes New Look At Breast Implant Safety

WEDNESDAY, March 20, 2019 -- Questions about breast implant safety are getting new attention from the U.S. Food and Drug Administration as thousands of women say their implants cause debilitating joint pain and fatigue. The claims have long been...

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Azar, Gottlieb Pen Op-ed Warning Of Regulatory Crackdown On E-cigarettes

Health and Human Services (HHS) Secretary Alex Azar and departing Food and Drug Administration (FDA) Commissioner Scott Gottlieb penned an op-ed in The Washington Post on Wednesday warning of a regulatory crackdown on the e-cigarette...

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Will Missed Endpoint Sink Magnetic Tx For Alzheimer's?

(MedPage Today) -- FDA panel to consider inconsistent trial data at Thursday meeting
Related topics: Alzheimer's Disease

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Bempedoic Acid: Modest Ldl Lowering Affirmed

(MedPage Today) -- CLEAR Wisdom completes the phase III picture; next step, FDA review

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Fda Approves First Drug For Treating Postpartum Depression — But Take A Look At The Price Tag

The U.S. Food and Drug Administration has approved the first drug specifically created for treating postpartum depression, providing hope for women suffering from the condition — as long as they can afford the treatment at upward of $34,000 a...
Related topics: Depression

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Many With Opioid Addiction Don't Get Meds That Can Help

WEDNESDAY, March 20, 2019 -- Most people struggling with opioid addiction lack access to FDA-approved medications that can head off withdrawal symptoms and quell their cravings, a new report finds. Methadone, buprenorphine and extended-release...
Related topics: Methadone

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Fda Made A Creepy Xbox Game To Warn Teens About The Dangers Of Smoking - Cnet

The game aims to scare you into healthy habits. It's also available on PC.
Related topics: Smoking

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Jazz Pharmaceuticals' Sleep Drug Nda Awaits Fda Decision

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Avadel Pharmaceuticals PLC. (AVDL):...
Related topics: Medical Research, Novartis

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There's Finally A Drug To Treat Postpartum Depression

It’s mind-boggling that, despite the amount of drug development and research on depression and mental health, there has been little on postpartum depression. As of Tuesday, that’s no longer the case: STAT News reports that the Food and Drug...
Related topics: Depression, Medical Research

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Food And Drug Administration Finally Ready To Listen To What Patients Are Saying About Silicone...

The Food and Drug Administration is beginning to take concerns over the potential health risks of silicone breast implants more seriously, after years of consumer complaints that were either dismissed or downplayed by the agency, doctors, and...

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