J&J warns doctors of Doxil cancer-drug shortage

2011-07-21T14:30:15Z

NEW YORK (Reuters) - Johnson & Johnson has cautioned doctors not to begin treatment with its Doxil cancer drug because of shortages of the medicine made by an outside manufacturer.

The company had informed doctors last month about a potential shortage of the injectable medicine, made by a unit of German drugmaker US Food and Drug Administration on Monday approved Incivek to treat hepatitis C when taken along with the current two-drug regimen, marking the second such drug approval this month.

"The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care," the FDA said.

Inci...

Vertex hepatitis C drug wins U.S. approval

2011-05-23T07:30:37Z

NEW YORK (Reuters) - Vertex Pharmaceuticals Inc's highly anticipated hepatitis C drug won U.S. approval, heralding a new era of treatment for the liver-destroying condition.

The approval, announced by the ...

US regulators approve new hepatitis C drug

2011-05-13T19:30:20Z

US regulators on Friday approved the first new treatment for hepatitis C in more than a decade, a Merck pharmaceutical known as Victrelis, to be taken with the current two-drug regimen.

Also known as boceprevir, the drug is a protease inhibitor that prevents the liver-disease causing virus from multiplying and studies have shown it "significantly" boosts recovery rates, the Food and Drug Admin...

FDA panel supports second new hepatitis C drug

2011-04-28T20:30:22Z

An expert panel on Thursday unanimously voted in support of a second new hepatitis C drug, Vertex Pharmaceuticals' telaprevir, which studies suggest can boost cure rates of the liver disease.

The advisory panel, which makes recommendations to the Food and Drug Administration, on Wednesday lent its ...

US panel gives nod to Merck hepatitis C drug

2011-04-27T18:30:24Z

A US government advisory committee on Wednesday unanimously voted to urge the Food and Drug Administration to approve a new drug made by Merck to fight hepatitis C, a disease which attacks the liver.

The advisory committee agreed by a vote of 18-0 that available data supports "approval of boceprevir for treatment of patients with chronic ...

Merck pitches hepatitis C drug to U.S. FDA panel

2011-04-27T08:30:25Z

SILVER SPRING, Maryland (Reuters) - An experimental drug for the liver-damaging hepatitis C virus offers an advance over the current decade-old treatment that cures only a minority of patients, maker Merck & Co told a U.S. advisory panel on Wednesday.

The Merck drug, boceprevir, and a rival from

FDA backs Vertex hepatitis drug efficacy, shares jump

2011-04-26T12:00:14Z

WASHINGTON (Reuters) - A hepatitis C drug from Vertex Pharmaceuticals Inc cured more patients than previously reported, U.S. health reviewers said, boosting the approval chances for a pill expected to transform treatment of the liver-destroying disease that afflicts millions.

Verte...

New drug hope for hepatitis C sufferers

2011-03-30T18:30:14Z

A cocktail of three drugs, including a new class of antiviral agent, has shown encouraging results in treating hepatitis C, a disease which attacks the liver, a study said Wednesday.

"This study represents a remarkable advance and a potential cure for people with hepatitis C who have not responded to previous therapy," said co-author Stuart Gordon, from the FDA warns weight loss drug may cause liver damage in rare cases

Federal health officials are warning consumers that the weight loss pill alli may cause severe liver damage in rare cases.

The Food and Drug Administration says it has added a warning about the risk to the label of the drug, which is sold over-the-counter by United States, a study said Wednesday.

In vitro experiments identified a protein that is essential to the reproductive cycle of the hepatitis C virus (HCV), the researchers said.

An altered synthetic version of the protein was found to destroy the virus' abi...

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

2010-10-24T10:10:24Z

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Voltaren Gel Adds Warnings About Hepatic Effects

2010-10-22T13:25:00Z

...

BRIEF-BioSphere Medical submits investigational device exemption for liver cancer treatment

2010-10-22T07:48:11Z

...

FDA Reviewing Possible Orlistat-Liver Damage Connection

2010-10-22T07:37:33Z

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FDA Investigating Weight-Loss Drug Over Reports of Liver Damage

2010-10-26T21:03:31Z

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Diet Drug Orlistat may be Associated with Liver Damage

2010-10-22T07:36:17Z

...

FDA Reviewing Adverse Events in Patients on Orlistat

2010-10-24T09:50:52Z

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FDA Investigating Weight-Loss Drug Over Reports of Liver Damage

2010-10-26T21:28:39Z

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FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat

2010-10-24T09:16:07Z

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U.S. probes Roche, Glaxo diet drug over liver injury

2010-04-16T10:40:21Z

WASHINGTON (Reuters) - U.S. health officials are reviewing reports of liver injury in people who took Roche Holding AG's weight loss drug Xenical or the over-the-counter version sold by GlaxoSmithKline.

The FDA probes liver damage with alli, only nonprescription weight loss drug approved in US

The Food and Drug Administration is investigating reports of liver damage in patients taking alli, the only nonprescription weight loss drug approved by the agency.

Regulators said Monday they have received more than 30 reports of liver damage in patients taking alli and Anadys Pharmaceuticals gets FDA clearance to begin study on hepatitis C therapy

Anadys Pharmaceuticals Inc. said Thursday the Food and Drug Administration cleared the company's plan for a midstage study on a potential combination therapy for hepatitis C.

The combination includes the drug...

Painkillers are about to get safer

2010-10-22T07:51:23Z

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Acetaminophen Not So Innocuous

2010-10-26T20:28:24Z

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Questions and answers about pain medicine dangers

2010-04-16T11:27:37Z

Questions and answers about painkiller dangers that prompted proposed limits on acetaminophen

A Food and Drug Administration panel has recommended limits on Tylenol and other drugs containing acetaminophen because of risks for liver failure. Maximum recommended doses for over-the-counter Tylenol would be reduced.

Patients fret over proposed Tylenol restrictions

2010-04-16T11:27:40Z

Proposed limits on Tylenol, a painkiller as common as pain itself, have left many consumers fearful, confused and wondering where to turn for relief.

The potential government crackdown on acetaminophen, Tylenol's main ingredient, would affect everyone from occasional pill poppers to chronic pain sufferers who rely on daily doses to make their lives more bearable.

If adopted by the FDA announces recall of Hydroxycut, used by dieters and body builders, for health risks

Government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death.

The Food and Drug Administration said t...

Hydroxycut Troubles! FDA Warns Consumers to Stop Taking Hydroxycut

2010-10-21T09:31:34Z

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ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

2010-10-23T23:04:38Z

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ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients

2010-10-23T18:37:33Z

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working on a drug called telaprevir for hepatitis C

2010-10-23T10:04:10Z

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Vertex Drug Shows Quick Results in Tough Hepatitis C Patients

2010-10-22T23:04:45Z

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One Drug, Many Tragedies

2010-10-26T20:16:57Z

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How to Avoid a Diet Scam

2010-10-19T10:17:13Z

...

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...

News on Food And Drug Administration

J&J warns doctors of Doxil cancer-drug shortage

Vertex hepatitis C drug wins U.S. approval

US regulators approve new hepatitis C drug

FDA panel supports second new hepatitis C drug

US panel gives nod to Merck hepatitis C drug

Merck pitches hepatitis C drug to U.S. FDA panel

FDA backs Vertex hepatitis drug efficacy, shares jump

New drug hope for hepatitis C sufferers

Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

Voltaren Gel Adds Warnings About Hepatic Effects

BRIEF-BioSphere Medical submits investigational device exemption for liver cancer treatment

FDA Reviewing Possible Orlistat-Liver Damage Connection

FDA Investigating Weight-Loss Drug Over Reports of Liver Damage

Diet Drug Orlistat may be Associated with Liver Damage

FDA Reviewing Adverse Events in Patients on Orlistat

FDA Investigating Weight-Loss Drug Over Reports of Liver Damage

FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat

U.S. probes Roche, Glaxo diet drug over liver injury

Painkillers are about to get safer

Acetaminophen Not So Innocuous

Questions and answers about pain medicine dangers

Patients fret over proposed Tylenol restrictions

Hydroxycut Troubles! FDA Warns Consumers to Stop Taking Hydroxycut

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients

working on a drug called telaprevir for hepatitis C

Vertex Drug Shows Quick Results in Tough Hepatitis C Patients

One Drug, Many Tragedies

How to Avoid a Diet Scam

Star Scientific-Smokeless Tobacco

FDA Obesity Treatments

Novartis Settlement

Abortion Pill 10 Years