reg

Showing 6 posts of 21 posts found.

Europe unites with Canada on safety regulation

January 15, 2008
Sales and Marketing reg, safety

European and Canadian regulators have forged a transatlantic agreement to exchange confidential information about the authorisation and safety of medicines. …

Champix linked to depression and suicidal thoughts

November 22, 2007
Sales and Marketing reg, safety

Pfizer has alerted US regulator the FDA to cases of depression and suicidal thoughts in patients taking its smoking cessation …

Liver problems delay Galvus launch

November 9, 2007
Sales and Marketing reg, safety

The European launch of new diabetes drug Galvus could be delayed by up to six months after small but significant …

FDA rejects painkiller Prexige

October 3, 2007
Sales and Marketing reg, safety

Novartis has received a "not approvable" letter from the FDA for its painkiller Prexige because of concerns about potential liver …

Regulators and pharma to join forces on drug safety monitoring

September 28, 2007
Sales and Marketing reg, safety

Regulators, the pharma industry and academic institutions are to come together in a new global alliance to research drug side-effects. …

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Zelnorm, the treatment for irritable bowel syndrome, has been withdrawn from the US market after the FDA raised concerns about …

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