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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.
The FDA will hold a public hearing on improving distribution of medication guides with risky medications after a lawmaker questioned the guides' distribution system, the agency announced. Read More
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 number of children receiving prescriptions for antidepressants dropped following warnings from the FDA about the increased risk of suicidal behavior associated with the drugs, according to a new study.
A new analysis of previously conducted studies showed no increase in coronary heart disease for women in their 50s who take hormone therapies close the start of menopause, according to an article in The Journal of the American Medical Association (JAMA).
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices.
The FDA needs a more active drug safety surveillance system and more authority over drugmakers when it finds serious adverse events, according to a leading consumer watchdog group.