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FDA

Showing 15 posts of 1442 posts found.

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FDA to probe Gilenya patient death

December 21, 2011
Sales and Marketing FDA, Novartis, gilenya

The FDA is investigating Novartis’s new multiple sclerosis treatment Gilenya after a patient died within hours of taking the drug. …

News
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Pfizer awaits verdict on contaminated site clean-up plan

December 13, 2011
Manufacturing and Production, Sales and Marketing FDA, Pfizer, manufacturing

The US Environmental Protection Agency is due to deliver a verdict on a $205 million proposal by Pfizer to clean …

News
EMA picture

EMA and FDA move closer on inspections

December 12, 2011
Manufacturing and Production EMA, FDA

The EMA and US FDA has taken a step closer to mutual recognition of manufacturing site inspections, launching a three-year …

News
Avastin picture

FDA pulls Roche’s Avastin for breast cancer

November 21, 2011
Research and Development, Sales and Marketing FDA, Roche, avastin

The FDA has pulled Avastin’s breast cancer licence in the US after the drug failed to prove its safety and …

News

Xarelto succeeds in new study

November 14, 2011
Sales and Marketing Bayer, FDA, J&J, JJ, Xarelto

In a new study J&J and Bayer’s blood thinner Xarelto reduced deaths in patients after a heart attack, which could …

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FDA boasts better approval rates than Europe

November 4, 2011
Medical Communications, Research and Development FDA, approvals

US regulator the FDA has approved more drugs and at a faster rate than its European counterpart.A new report by …

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Obama takes action to curb medicine shortages

November 1, 2011
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Obama, drugs

US President Barack Obama has ordered the FDA and Department of Justice to take action to reduce and prevent medicine …

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Avastin pack shot

FDA’s rejection of Avastin creates conflict

October 31, 2011
Research and Development, Sales and Marketing FDA, avastin, breast cancer

Oncology experts have expressed concern at the FDA’s rejection of Roche’s Avastin for the treatment of advanced breast cancer. A …

News

Daiichi Sankyo subsidiary gets FDA warning

September 15, 2011
Daiichi Sankyo, FDA, Luitpold

Daiichi Sankyo’s US subsidiary Luitpold Pharmaceuticals has been sent a warning letter by the FDA for “significant” and repeated quality …

News
US Food and Drug Administration

FDA unveils changes to cancer drug review

September 14, 2011
Research and Development, Sales and Marketing Cancer, FDA, regulatory affairs

The FDA has unveiled a reorganisation of how it reviews new cancer drugs, and says the new approach should help …

News

Shire’s Firazyr gains US approval after initial setback

September 1, 2011
Sales and Marketing FDA, Firazyr, Shire

After three years of waiting Shire’s Firazyr has been approved by the FDA for sudden attacks of swelling. The US …

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FDA wants more information on Novartis arthritis drug

August 31, 2011
Sales and Marketing FDA, Ilaris, Novarits, canakinumab

The FDA has asked Novartis for more information on its gouty arthritis drug canakinumab. The regulator’s request came in a …

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FDA approves Pfizer’s lung cancer drug Xalkori

August 30, 2011
Sales and Marketing FDA, Pfizer, Xalkori, crizotinib

Pfizer’s lung cancer drug Xalkori has been approved by the FDA, a month ahead of schedule. Xalkori (crizotinib) is now …

News

Ranbaxy closes down troubled liquid formulations plant

August 12, 2011
Manufacturing and Production FDA, Ranbaxy, pharma manufacturing news, quality control

Indian drugmaker Ranbaxy Laboratories has decided to close down a manufacturing facility in the USA which has been under scrutiny …

News

Shared API inspections project declared a success

August 9, 2011
Manufacturing and Production API, EMA, FDA, TGA, pharma manufacturing news, regulatory inspections

A two-year facility inspection programme carried out by regulators in the USA, Europe and Australia has been deemed a success …

News
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