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GlaxoSmithKline (GSK) and Adolor stopped development of their bowel-disorder drug and withdrew an application because of increased risk of heart attacks, benign and malignant tumors and bone fractures, the companies said.
The FDA’s Arthritis Advisory Committee voted 20-1 against recommending approval of Merck’s Arcoxia, a potential successor to Vioxx as a treatment for arthritis pain.
GlaxoSmithKline (GSK) and Adolor stopped development of their bowel-disorder drug and withdrew an application because of increased risk of heart attacks, benign and malignant tumors and bone fractures, the companies said.
An increased risk of side effects from Merck’s potential Vioxx successor Arcoxia indicates the drug should not be approved unless it fills an unmet need, an FDA employee told an advisory committee.
The FDA has released documents questioning a new prostate cancer drug’s efficacy days before an agency advisory committee meets to discuss the product.
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 is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form data in extensible markup language based on the operational data model developed by the Clinical Data Interchange Standards Consortium.