News on Food And Drug Administration

FDA sets path for key new diabetes device

2011-12-01T15:30:11Z

CHICAGO (Reuters) - The U.S. Food and Drug Administration issued new guidelines to medical device makers developing a potentially revolutionary device for type 1 diabetes, saying they should speed its delivery to patients.

The guidelines reflect m...

FDA: Diabetes device plan may help patients faster

2011-12-01T10:00:46Z

CHICAGO (Reuters) - The U.S. Food and Drug Administration issued new guidelines on Thursday for the development of a potentially revolutionary device to treat type 1 diabetes that will give manufacturers 'maximum flexibility' in getting it to U.S. patie...

Insight: Diabetes breakthrough stalled in safety debate

2011-12-01T06:00:22Z

CHICAGO (Reuters) - It's a dream of medical science that looks tantalizingly within reach: the artificial pancreas, a potential breakthrough treatment for the scourge of type 1 diabetes.

Meant to mimic the function of a real pancreas, the artificial version is a complex device that combines a pager-sized continuous glucose monitor and sensor that...

Panel rejects AstraZeneca, Bristol diabetes pill

2011-07-19T14:00:10Z

SILVER SPRING, Maryland (Reuters) - U.S. advisers rejected a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb over concerns about liver and can...

Scientists getting closer to artificial pancreas

2011-06-27T08:30:49Z

CHICAGO (Reuters) - Researchers are coming closer to developing an "artificial pancreas," a long-sought system of insulin pumps and glucose sensors that deliver insulin to diabetics, mimicking the function of a real pancreas.

The devices have been in development for more than three decades, but lawmakers and diabetes advocates are ramping up the ...

Analysis: Scientists getting closer to artificial pancreas

2011-06-24T14:30:14Z

The devices have been in development for more than three decades, but lawmakers and diabetes advocates are ramping up the ...

Common drug combo spikes blood sugar: study

2011-05-25T16:30:15Z

An anti-depressant and a cholesterol lowering drug, taken together by as many as one million people in the United States, may cause a spike in blood sugar levels, researchers said Wednesday.

Paxil and the anti-cholesterol drug Pravachol do not have this ...

J&J Animas unit recalls leaky insulin cartridges

2011-03-08T11:30:29Z

NEW YORK (Reuters) - Johnson & Johnson, which has been beset by a seemingly endless stream of product recalls, has recalled hundreds of thousands of potentially leaky insulin pump cartridges that could lead to serious health problems and death.

It also has been warned by the Food and Drug Administra...

Blood sugar meters may give inaccurate readings

2011-01-14T13:30:35Z

NEW YORK (Reuters Health) - In a new study, portable meters used to gauge blood sugar levels in pregnant women with diabetes gave readings that differed from lab tests by up to 16 percent.

That kind of inaccuracy is concerning, researchers say, because small differences in blood sugar during pregnancy can have potentially serious consequences for the mother and baby.

But that doesn't m...

MannKind's inhaled insulin verdict delayed

2010-12-28T04:30:19Z

(Reuters) - Inhaled-insulin developer MannKind Corp said the U.S. health regulator would not be able to complete the review of Afrezza by December 29 and would require about four more weeks.

The company said it was notified of the delay by the Reuters) - Abbott Laboratories is recalling as many as 359 million blood glucose testing strips that could give false results to diabetics, the company and U.S. regulators said on Wednesday.

Abbott said the strips -- used with its ...

Abbott recalls millions of diabetes testing strips

2010-12-22T11:00:31Z

Abbott Laboratories recalls millions of diabetes testing strips over incorrect readings

The Food and Drug Administration said Wednesday that Abbott Laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings.

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Abbott recall diabetes test strips in U.S.

2010-12-22T11:00:16Z

WASHINGTON (Reuters) - Abbott Laboratories is recalling as many as 359 million blood glucose testing strips that could give false results to diabetics, the company and U.S. regulators said on Wednesday.

Abbott said the strips -- used with its ...

How to Test Your Blood Sugar

2010-11-29T15:01:53Z

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How to Prepare for the FDA Advisory Committee

2010-11-29T14:37:26Z

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Despite FDA Warning, Avandia Use Varies Across U.S.

2010-11-29T14:42:23Z

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Despite FDA Warning, Avandia Use Varies Across U.S.

2010-11-29T14:35:08Z

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Phenformin

2010-11-30T13:48:36Z

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Otelixizumab

2010-11-30T13:48:30Z

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Vildagliptin

2010-11-30T13:49:31Z

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Arena Pharmaceuticals' Fantasy Land

2010-11-29T14:40:28Z

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Safety Data Worsens For Arena's Obesity Drug

2010-11-29T14:40:24Z

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Arena Fat Drug Enters FDA Purgatory

2010-11-29T14:40:24Z

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Arena's Fantasy Land

2010-11-29T14:40:24Z

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Dark Days In Diabetes

2010-11-29T14:43:41Z

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Amylin Pharmaceuticals CEO Discusses Q3 2010 Results - Earnings Call Transcript

2010-11-29T14:49:08Z

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FDA Rejects Biodel’s Diabetes Drug: Biotech's Latest Mishaps

2010-11-29T14:49:08Z

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DexCom CEO Discusses Q3 2010 Results - Earnings Call Transcript

2010-11-29T14:49:07Z

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ChromeMate

2010-11-30T13:09:25Z

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Concerns about the safety of Avandia

2010-11-29T15:18:53Z

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Side effects of Adderall

2010-11-29T15:21:14Z

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Liraglutide

2010-11-30T13:11:08Z

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First oral insulin medication for diabetics: Generex Oral-lyn

2010-11-29T15:20:55Z

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Bydureon

2010-11-05T06:44:32Z

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FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta

2010-11-04T07:45:00Z

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Movie reviews: Food Inc.

2010-11-04T15:39:53Z

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MannKind CEO Discusses Q3 2010 Results – Earnings Call Transcript

2010-11-03T16:19:57Z

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Clinical Trials Update: Oct. 29, 2010

2010-11-03T17:51:22Z

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Amylin Pharmaceuticals' Stock Trashed Without Justification; Opportunity for Long Term Investors

2010-10-26T13:20:17Z

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Amylin Pharmaceuticals: Will it Navigate the Rough Waters Ahead?

2010-10-26T09:58:55Z

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5 High-Impact Biotech Catalysts to Watch This Week

2010-10-26T09:58:51Z

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Childhood Diabetes Can Be Reversed...Stop It Now

2010-11-03T09:44:31Z

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Diabetes - Cinnamon Bark Benefits and Risks

2010-11-03T09:46:22Z

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Diabetes and Dietary Supplements

2010-11-03T09:44:26Z

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Herbal Remedies Facts

2010-11-03T09:48:53Z

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FDA orders new warnings on prostate cancer drugs

2010-10-20T15:30:30Z

WASHINGTON (Reuters) - Certain hormone treatments for prostate cancer must carry new warnings about an increased risk of diabetes and heart problems, the U.S. Food and Drug Administration said on Wednesday.

The medications include Avandia will no longer be available to patients in Europe and will be restricted in the US over fears it increases the risk of heart attack and strokes, regulators said Thursday.

The controversial drug made by British company GlaxoSmithKline would be pulled in Europe within the next few months,...

FDA Restricts Use of Diabetes Drug Avandia

2010-09-23T15:04:07Z

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US limits Avandia diabetes drug use, falls short of ban

2010-09-23T10:15:25Z

The top US food regulator Thursday severely restricted the use of the controversial diabetes drug, Avandia, made by British firm GlaxoSmithKline, but stopped short of an outright ban.

The Food and Drug Administration said in a statement it was taking the s...

US restricts, EU bans controversial diabetes pill

2010-09-23T13:56:04Z

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FDA keeps diabetes pill with heart risks on market

2010-09-23T08:30:30Z

FDA leaves diabetes pill Avandia on market but restricts access due to heart attack risks

Federal health regulators will allow GlaxoSmithKline to continue selling a controversial diabetes pill but will restrict access to the once-blockbuster drug because of heart attack risks.

The

FDA significantly restricts access to the diabetes drug Avandia

2010-09-23T12:38:36Z

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FDA restricts use of risky diabetes drug Avandia. What are safer options?

2010-09-23T11:03:19Z

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It’s a Split Decision for Avandia: U.S. Says Yes, Europe Says Non

2010-09-23T11:12:17Z

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Is Stevia Safe for People With Diabetes?

2010-09-21T11:44:22Z

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FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure

2010-09-21T14:00:02Z

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What Are Fenugreek Capsules?

2010-11-05T11:03:10Z

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What Are Thiazolidinediones?

2010-11-05T10:07:41Z

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What Is Tinospora Cordifolia?

2010-11-05T10:09:01Z

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Interaction Between Saxagliptin & Digoxin

2010-11-02T14:38:29Z

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Avandia: Less Risky in Younger, Healthier Patients?

2010-09-11T13:58:34Z

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Another Twist in the Chronicles of Avandia!

2010-11-02T14:14:45Z

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FDA panel votes to keep Avandia available

2010-11-02T13:56:29Z

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DexCom, Inc.Q2 2010 Earnings Call Transcript

2010-11-02T12:11:04Z

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FDA OKs new type of diabetes monitoring system

2010-11-02T13:28:03Z

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MannKind Corp. Q2 2010 Earnings Call Transcript

2010-11-02T12:10:48Z

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What is Chromium?

2010-11-05T10:05:29Z

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Diabetics Urged to Confer With Their Doctor About Avandia Use

2010-09-10T20:11:28Z

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FDA Panel Seems Skeptical Over Key Avandia Data

2010-09-10T20:11:39Z

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Avandia's future murky after FDA panel vote

2010-11-02T12:43:42Z

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Mannkind Tries Again With Inhaled Insulin

2010-11-02T12:09:24Z

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Bristol-Myers Squibb Q2 2010 Earnings Call Transcript

2010-11-02T12:09:11Z

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Planned Study of Avandia in Doubt After FDA Review

2010-11-02T14:03:59Z

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US Agency Puts Hold On Much-Debated Avandia Study

2010-11-02T12:39:37Z

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FDA issues hold on much-debated Avandia study

2010-07-21T09:45:22Z

FDA bars new patients from enrolling in safety study of diabetes drug tied to heart risks

Federal health officials say new patients should not be enrolled in a study of GlaxoSmithKline's controversial diabetes pill Avandia, after experts last week said the drug increases heart risks.

The CHICAGO (Reuters) - The U.S. Food and Drug Administration has warned Abbott Laboratories' diabetes care unit about manufacturing problems at its Alameda,

FDA alerts to ongoing olmesartan cardiovascular review

2010-11-02T13:56:12Z

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Diabetes Drug Shakedown Yields Unclear Decision from FDA Committee

2010-09-10T14:44:56Z

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FDA Panel Math: How Avandia Vote is Being Played

2010-11-02T14:14:39Z

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Final ruling on controversial diabetes drug

2010-11-02T13:11:00Z

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Star Scientific-Smokeless Tobacco

2011-01-04T12:31:04Z

FILE - In this Sept. 28, 2010 file photo, smokeless tobacco products, including Ariva, are displayed in Richmond, Va. Tobacco maker Star Scientific Inc. says it has developed a moist smokeless tobacco with lower levels of cancer-causing chemicals than any other tobacco product now on the market. Star Scientific says the "modified-risk" label that the

FDA Obesity Treatments

2010-12-03T21:31:29Z

In this product photograph provided by Allergan, Inc., the LAP-BAND System is displayed. An FDA panel will vote whether to recommend expanding the use of a stomach shrinking band currently approved just for the morbidly obese. (AP Photo/Allergan, Inc.) NO SALES

Sen. Tom Harkin, D-Iowa, speaks to reporters in Des Moines, Iowa. The Food and Drug Administration would have to step up inspections of food processors under legislation the Senate is expected to pass this week. The bill, which...

Novartis Settlement

2010-09-30T12:45:34Z

U.S. Attorney Zane David Memeger, from left, speaks as Nicholas DiGiulio from the Department of Health and Human Services and Thomas Doyle from the Food and Drug Administra...

Abortion Pill 10 Years

2010-09-26T21:30:31Z

FILE - In this Jan. 11, 1995 file photo, inventor of the RU-486 abortion-inducing drug, Professor Emile-Etienne Beaulieu, holds the pills in Paris. Ten years ago, on Sept. 28, 2000, after long and bitter debate, the Food and Drug Administration approved use of the abortion pill by American wom...