Tag Archives: U.S. Food and Drug Administration

Drug regulators in China, US and Europe out of the gates in 2020 with a whole month’s worth of action.

Slowly at first, then accelerating recently in its domestic and global footprint in drug research and regulation, China and its National Medical Products Administration (NMPA) has been on a tear…. Read more »

China’s BeiGene gets nod from FDA for lymphoma med; significance extends further than just a win for one Chinese biotech.

The News: The US Food and Drug Administration has given the green light to market a blood cancer drug from Beijing-based BeiGene Ltd., paving the way for American patients to access a Chinese… Read more »

FDA panel unanimously backs use of Amarin’s fish-oil heart drug; action could produce gigantic profit haul.

The News: Government health experts recently recommended broader use of a prescription-strength fish oil drug to help many more patients at risk for heart attack, stroke and related health problems…. Read more »

In a seeming role-reversal, FDA steps up action over Thanksgiving week while EMA goes on holiday.

Although usually thought of as a well-deserved respite from governmental rulings, the US Food and Drug Administration seized on Thanksgiving week as a demonstration of its zeal to pump out… Read more »

FDA goes on a rulings binge

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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 »