Tag Archives: U.S. Food and Drug Administration

FDA goes on a rulings binge

      No Comments on FDA goes on a rulings binge

FDA ROUNDUP: In one of the busiest rulings binges of the year, the US Food and Drug Administration last week approved an assortment of pharmaceuticals, medical devices, an AI algorithm… Read more »

All three of the world’s major drug regulators have busy week despite heat waves, political chaos. You know; the usual.

Last week was a rare case where the world’s leading drugs and devices regulators were all in action simultaneously. The US Food and Drug Administration (FDA), the European Medicines Agency… Read more »

European drug regulator comes out of hibernation in new Dutch headquarters, rivaling the FDA with rulings; well, just for one week.

It may have taken nearly 6 months and perhaps a Fourth of July holiday-shortened work week here in the US, but the European Medicines Agency (EMA) finally issued some new… Read more »

Close (but not too close) encounters with God confer mental health benefits, say researchers at Johns Hopkins. This definitely isn’t your typical medical article.

The News: Profound religious experiences are linked to lasting mental health benefits, new research suggests. In a survey study of more than 4000 individuals, those who reported having profound personal… Read more »

FDA clears psilocybin for testing as breakthrough therapy

UPDATE: FDA permits psilocybin to be tested for refractory depression; grants Breakthrough Therapy designation for magic mushrooms psychedelic compound. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy… Read more »

October wraps up healthcare IPOs with another strong week as 2018 biotech explosion still on record pace.

The News: The Wall Street Journal reports that the pace of biotech IPOs in on track for a near-record year, although many are riskier due to being in earlier stages of development…. Read more »

Stodgy Johns Hopkins wants FDA to clear psilocybin mushrooms for depression. Here’s what you need to know (or recall) about the differences between magic shrooms and, say, LSD.

The News: Researchers from Johns Hopkins University (Baltimore) have recommended that psilocybin, the active compound in hallucinogenic mushrooms, be reclassified for medical use, potentially paving the way for the psychedelic… Read more »

Insys attempting “Phoenix” impersonation as key Q1 earnings slated for Tuesday. Analysts say Buy, but is now the time?

The News: A former Insys Therapeutics Inc. (Chandler AZ) sales representative was recently sentenced to six months of home confinement after admitting that she participated in a scheme to pay… Read more »

Biotech IPO tsunami continues even as stocks sag following FDA chief’s drug-price rant.

The News: US Food and Drug Administration chief Scott Gottlieb on Thursday (May 3, 2018) questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law,… Read more »