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GlaxoSmithKline’s (GSK) kinase inhibitor Tykerb gained FDA approval for use in combination with Roche’s oral chemotherapeutic Xeloda for the treatment of advanced metastatic breast cancer — specifically in tumors that produce an excess of the HER2 protein.
The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.
Novartis will position its newly approved antihypertensive Tekturna as a new treatment option in a therapeutic category where nearly seven out of 10 patients do not reach their respective blood pressure targets, the company said.
ZymoGenetics said the FDA has informed the company that it will not be required to conduct an additional Phase III clinical trial of its recombinant human Thrombin (rhThrombin), which aids in controlling bleeding during surgery.
The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.
The FDA has cleared Pfizer’s Lipitor for five new heart disease indications, including the reduction of the risk of hospitalization due to heart failure.
Novartis will position its newly approved antihypertensive Tekturna as a new treatment option in a therapeutic category where nearly seven out of 10 patients do not reach their respective blood pressure targets, the company said.
The FDA approved Shire’s amphetamine-based attention deficit/hyperactivity disorder (ADHD) drug Vyvanse, which has a lower risk of abuse than similar drugs, the company announced.