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FDA approves leucovorin – but not for autism

The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?

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FDA cuts testing requirements for biosimilars once again

The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.

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CBER chief Vinay Prasad to leave FDA once again

For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.

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PepGen slumps as FDA places hold on lead drug

Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.

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FDA ramps up its pushback against compounded GLP-1s

In a move that will please Novo Nordisk and Eli Lilly, the FDA sent warnings to 30 telehealth firms, accusing them of illegally marketing GLP-1 drugs.

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New FDA knockback hits uniQure and Huntington patients hard

uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme.

FDA approves leucovorin – but not for autism

FDA cuts testing requirements for biosimilars once again

CBER chief Vinay Prasad to leave FDA once again

PepGen slumps as FDA places hold on lead drug

FDA ramps up its pushback against compounded GLP-1s

New FDA knockback hits uniQure and Huntington patients hard

Repligen builds in cell therapy with $1.5bn BioLife takeover

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

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