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FDA

Showing 15 posts of 1410 posts found.

New FDA head aims for aggressive enforcement

August 11, 2009
Research and Development, Sales and Marketing FDA, US, drug safety

The new head of US regulator the FDA has set out a vision to support public health, through tighter laws …

News

TNF blockers must carry children’s cancer warning

August 7, 2009
Research and Development, Sales and Marketing FDA, RA, TNF

The FDA has ruled that TNF blocker drugs should carry new warnings of the increased risk of certain cancers for …

News

FDA blocks Teva from selling vet drugs and warns Apotex

August 6, 2009
Manufacturing and Production Apotex, FDA, Teva

The FDA’s clampdown on quality standards continues apace, with Teva’s animal health unit in Missouri and an Apotex plant in …

News

US approval boosts Plavix competitor

July 14, 2009
Research and Development, Sales and Marketing Effient, FDA, US, lilly

US regulator the FDA has approved Lilly and Daiichi Sankyo's Effient, a rival treatment to the world's best-selling blood-thinning drug …

News

Writing on the wall for ‘pay to delay’ generics deals

July 9, 2009
Research and Development, Sales and Marketing FDA, US, generics

Deals allowing US pharma companies to pay generics competitors to delay the launch of rival products should be ended, according …

News

Genzyme’s woes are a boost for Shire and Protalix

July 9, 2009
Research and Development, Sales and Marketing FDA, Genzyme, US

The contamination problems at a plant used by Genzyme to manufacture a drug for Gaucher disease have prompted the US …

News

Depression warnings for Chantix and Zyban

July 7, 2009
Research and Development, Sales and Marketing Chantix, FDA, US, drug safety

Pfizer and GSK's smoking cessations drugs will have to carry strong warnings of depression and other mental health adverse events …

News

FDA to improve transparency

June 3, 2009
Research and Development FDA, US

The US medicines regulator is to boost the transparency around its decision-making, in connection with President Obama's aim to make …

News

Coast first casualty in US overhaul of IRB system

May 5, 2009
Research and Development FDA, US

A US company offering institutional review board services to sponsors of clinical trials has been forced to close its doors …

News

Sanofi boosted by Multaq vote of approval

March 19, 2009
Research and Development, Sales and Marketing FDA, Multaq, Sanofi, US

An FDA committee has recommended Sanofi-Aventis' new atrial fibrillation treatment Multaq, the company's most important late-stage drug. The FDA cardiovascular …

News

Hamburg appointed as new FDA head

March 18, 2009
Research and Development FDA

A leading public health expert has been appointed as the new head of the FDA. President Obama has selected Dr …

News

Blow for Genzyme as FDA finds fault with Allston facility

March 13, 2009
Research and Development, Sales and Marketing FDA, Genzyme

The chances of approval for Genzyme's new Pompe disease drug Lumizyme have diminished dramatically after the US Food and Drug …

News

FDA finalises transgenic animals guide

January 23, 2009
Research and Development, Sales and Marketing FDA, US, reg

The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA. …

News

FDA moves to make imports safer

January 16, 2009
Manufacturing and Production FDA, supply chain

The Food and Drug Administration is stepping up efforts to prevent counterfeit and contaminated  medicines entering the US, and is …

News

Novartis’ Zelnorm pulled from market after safety concerns

April 2, 2007
Sales and Marketing FDA, reg

Zelnorm, the treatment for irritable bowel syndrome, has been withdrawn from the US market after the FDA raised concerns about …

News

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