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The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Monday to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More
A panel of FDA advisors Nov. 14 overwhelmingly voted against approval of Sanofi’s Lemtrada for an expanded indication to treat relapsing multiple sclerosis (MS). Read More
FDA advisers overwhelmingly voted Nov. 14 to recommend approval of Vanda’s sleep drug tasimelteon for the visually impaired despite some concern over a clinical trial’s primary endpoint. Read More
Johnson and Johnson’s guilty plea and $2.2 billion settlement with the U.S. government to resolve off-label marketing claims for its anti-psychotic Risperdal leaves the company with more legal fights ahead of it. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
Despite a recent ruling by the White House Office of Management and Budget (OMB) that $85 million in already collected fiscal 2013 FDA user fees remain impounded and unavailable for the agency to use, no plans have yet emerged in Congress to free up the funds. Read More