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Two new cancer Priority Reviews for Roche

Roche has announced that the FDA has granted Priority Review to two of its drugs – personalised lung cancer medicine entrectinib and lymphoma treatment polat

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Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

Janssen's esketamine depression drug set for key panel vote

Janssen’s potential depression treatment made from esketamine – a version of the substance notoriously used illegally as a party drug – is to be reviewed by advisers to the FDA at a crunch

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FDA clears AI wearable to monitor hospital patients

An artificial intelligence (AI)-powered wearable, Current Health, has received clearance from the FDA for use in hospital care.

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Daiichi gets speedy FDA review for rare cancer drug

Daiichi Sankyo has been given a priority review from the FDA for pexidartinib, which is vying to become the first systemic drug therapy for rare cancer tenosynovial giant cell tumour (TGCT).

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FDA publishes premarket guidance on combination products

The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device. In a statem

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Alkermes rebuffed by FDA on antidepressant

Alkermes is facing a significant delay for its ALKS 5461 candidate for major depressive disorder after the FDA turned down its marketing application.

Two new cancer Priority Reviews for Roche

Janssen's esketamine depression drug set for key panel vote

FDA clears AI wearable to monitor hospital patients

Daiichi gets speedy FDA review for rare cancer drug

FDA publishes premarket guidance on combination products

Alkermes rebuffed by FDA on antidepressant

Third Rock in $2bn drug-hunting pact with China's Funnel

Securing your ROI: Turning post-acquisition integration into...

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