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The government shutdown could soon jeopardize highly anticipated new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to a STAT analysis of upcoming regulatory decision dates

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The FDA said that it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten

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In just 10 months, the sixth-largest company in America shipped more than 3 million prescription opioids — nearly 10,000 pills a day on average — to a single pharmacy in a Southern West Virginia town with only 400 residents, according to a congressional report released Wednesday

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The FDA went along. Is the newest opioid any better? In the midst of a national opioid crisis, how badly do we need another formidable painkiller?

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Stakeholders stress need for greater transparency, improved payment. Drug shortages cause higher rates of medication errors, delayed treatment of life-saving medications and inferior outcomes, and even death, said our Yoram Unguru, MD

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Watch live online now – FDA Drug Shortages Task Force Public Meeting on Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions – presenters include our Yoram Unguru

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Spinal-cord stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an AP investigation found. They account for the third-highest number of medical device injury reports to the FDA, with more than 80,000 incidents flagged since 2008

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Can the agency simultaneously push e-cigarettes away from eager teens and toward longtime smokers who might benefit from them?

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