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UCB bags FDA okay for first drug to treat rare disease TK2d

People living with thymidine kinase 2 deficiency (TK2d), a vanishingly rare and often fatal genetic disorder, finally have an approved therapy.

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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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Medical group advises against leucovorin for autism

The American Academy of Paediatrics has warned against leucovorin as a treatment for autism, citing a lack of evidence on safety and efficacy.

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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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Falling flu vaccine sales in US stall CSL's Seqirus spinout

CSL says flu vaccination rates in the US are expected to fall 12% to 14% this year, and have scuppered its plan to spin out its vaccines unit Seqirus.

UCB bags FDA okay for first drug to treat rare disease TK2d

uniQure poleaxed as FDA blocks Huntington's therapy

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

Medical group advises against leucovorin for autism

FDA plan will cut testing requirements for biosimilars

Falling flu vaccine sales in US stall CSL's Seqirus spinout

Lilly bags FDA okay for Wegovy pill rival orforglipron

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