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uniQure poleaxed as FDA blocks Huntington's therapy

uniQure has revealed that the FDA has said it is not prepared to review its Huntington's gene therapy in what seems to be a change in policy.

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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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"Significant shift" as NICE widens prostate cancer drug use

NICE has changed unpopular guidance on abiraterone for hormone-sensitive prostate cancer after the entry of generics into the UK market.

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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.

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Chugai buys 'Asia lag' firm Renalys for $98m upfront

Chugai Pharma has reached a deal to buy Renalys Pharma, a company set up to bring therapies developed elsewhere to markets in Asia.

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A male HCP discusses treatment with an older male patient

Bayer's prostate cancer drug Nubeqa cleared for NHS use

Thousands of men living with incurable prostate cancer will be able to access an easier-to-tolerate treatment from Bayer, thanks to new NICE guidance.

uniQure poleaxed as FDA blocks Huntington's therapy

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

"Significant shift" as NICE widens prostate cancer drug use

FDA plan will cut testing requirements for biosimilars

Chugai buys 'Asia lag' firm Renalys for $98m upfront

Bayer's prostate cancer drug Nubeqa cleared for NHS use

Pharvaris plans filings for HAE drug after pivotal trial win

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

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