A tiny Texas firm making helmet-style ventilators is working around the clock to meet skyrocketing demand, and it has no plans to raise the product’s $162 price tag.   Sea-Long Medical Systems Inc. usually ships a few dozen devices each week. Their new goal: 50,000.   It’s…

Regulatory gaps and legal roadblocks are frustrating efforts to pinpoint the cause of critical lung disease suddenly striking teens and young adults who vape.  Until now, the FDA has neither reviewed nor regulated vape products. But 193 potential cases of lung disease and…

For months, Purdue Pharma has been negotiating a $10-12 billion settlement that would resolve some 2,000 lawsuits against the company, NBC News reported yesterday—a day after a landmark ruling against Johnson & Johnson for its role in Oklahoma’s opioid crisis.  

Fecal microbiota transplants have been kicking C.diff infections for decades. In 2013, they were granted a murky “investigational” classification from the FDA.  But when an FMT recipient died in June after contracting drug-resistant bacteria, the FDA deployed a safety…

From 2008-2018, a third of clinical trials that produced new cancer drugs failed to report the race of participants. A new study also found that even among trials that did, participation numbers were not representative of the general cancer patient population: just 6%…

Yesterday the FDA greenlit a hugely promising drug for a form of TB that has long been a death sentence, The New York Times reports.   Pretomanid is part of a 3-drug regimen that proved 90% effective against extensively drug-resistant TB, according to preliminary trial…

Juul paid for access to young people, according to testimony in a US Congressional hearing to determine the company’s role in a youth vaping epidemic that has spiraled since the company’s 2015 launch.  

In 2012, the FDA approved Amyvid dye, the first Alzheimer’s biomarker test. But the dye requires a PET scan and costs thousands of dollars.  Researchers are looking for better biomarkers for earlier diagnosis and improved drug research. The tau protein, for example, is…

David Sackler says his family isn’t to blame for the opioid crisis. In an exclusive interview with Vanity Fair, Sackler hit back against widespread accusations that the family firm, Purdue Pharma, spurred the crisis with aggressive and misleading marketing of OxyContin.

Minnesota mom Lija Greenseid recently led a caravan to the Canadian border on a quest for insulin her daughter’s Type 1 diabetes.   Outraged by the near-doubling in cost of insulin in the US in recent years, she organized a small group of Americans to Ontario, where they…