Pfizer’s Wyeth loses bid to duck hormone-therapy lawsuit
Pfizer Inc’s Wyeth unit must face a class action alleging that the drugmaker misled California women by downplaying risks including breast cancer associated with its hormone-replacement therapy products, a federal judge has ruled.
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Kratom: It’s legal in Michigan and people are using it to get high. Here’s what to know
Users hail kratom — which is sold at gas stations, smoke shops and online —as a miracle cure for pain, fatigue, anxiety and even opioid addiction.
But many doctors say kratom (pronounced KRAY-tum or KRAH-tum) is dangerous because it works like an opioid, can make users high and can also be habit-forming. Plus, experts say,...
FDA warns of cybersecurity risk to certain Medtronic insulin pumps
The U.S. Food and Drug Administration said on Thursday that certain insulin pumps of Medtronic Plc were being recalled due to a potential risk of them being hacked.
The drug regulator said it was not aware of any confirmed reports of patient harm related to the potential cybersecurity risks.
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FDA releases millions of records of incidents involving medical devices
The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.
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U.S. group says Novartis MS drug price out of line with benefit
A U.S. group that reviews the value of medicines issued a critical report on Novartis’s new multiple sclerosis drug Mayzent, calling its $88,561 list price “far out of line” compared with its benefits for patients.
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FDA Recalls Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm
The U.S. Food and Drug Administration (FDA) has issued a class I recall for the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm, manufactured by Cook Incorporated, due to "multiple complaints" regarding a high recurrence rate of balloons bursting below the rated burst pressure. According to the Agency, potential implications for using...
U.S. cities propose framework for nationwide opioid settlement talks
Lawyers for counties and municipalities suing drug manufacturers and distributors over their alleged roles in the U.S. opioid epidemic on Friday pitched a novel plan that would bring all 24,500 communities nationally into their negotiations for billions of dollars in settlements.
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Drugmakers fight rule to disclose prices in TV ads
A bid by the Trump administration to shine light on the high costs of prescription drugs prompted legal resistance Friday by three major pharmaceutical companies.
Amgen, Eli Lilly, and Merck sued the Department of Health and Human Services in a bid to block new rules requiring that companies disclose the “list price’’ of their drugs...
Fecal Transplant Is Linked to a Patient’s Death, the F.D.A. Warns
The agency said two patients have received donated stool that had not been screened for drug-resistant germs...
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Schumer calls on FDA to review all chemicals used in sunscreen
Sen. Chuck Schumer on Sunday said he’s asking the FDA to review all of the ingredients of sunscreen products to ensure consumers don’t get burned by chemicals that could “seep into the bloodstream.”
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