FDA

News

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

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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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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

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

News

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