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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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 »