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Dismay as FDA declines to approve Biohaven's ataxia drug

Biohaven's troriluzole candidate for spinocerebellar ataxia (SCA) has been turned down by the FDA, in another sign of a tougher stance by the agency.

R&D

Biotech’s biggest challenge isn’t scientific, but political ...

We speak to James Roosevelt Jr, a longtime healthcare leader, former associate commissioner of social security for retirement policy & grandson of FDR

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CDER head Tidmarsh 'on leave' and is sued by drugmaker

George Tidmarsh is no longer at the helm of CDER and is facing a lawsuit claiming he abused his position there to harm a former business associate.

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FDA plan will cut testing requirements for biosimilars

The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.

News

FDA hands out first national priority vouchers to nine firms

The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher programme.

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UK and US agencies team up for medtech, AI regulation

The regulatory authorities in the UK and US have agreed to work more closely together on the regulation of medical technologies and AI.

Dismay as FDA declines to approve Biohaven's ataxia drug

Biotech’s biggest challenge isn’t scientific, but political ...

CDER head Tidmarsh 'on leave' and is sued by drugmaker

FDA plan will cut testing requirements for biosimilars

FDA hands out first national priority vouchers to nine firms

UK and US agencies team up for medtech, AI regulation

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

FDA

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