regulatory | pharmaphorum

Wednesday 17 December 2025

regulatory

News

FDA rejects ImmunityBio’s bladder cancer drug

FDA rejects ImmunityBio’s bladder cancer drug

Shares in ImmunityBio were in freefall today after it revealed the FDA had rejected its marketing application for Anktiva as a treatment for bladder cancer.

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FDA sets out its thinking on decentralised clinical trials

FDA sets out its thinking on decentralised clinical trials

The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as di

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FDA won’t approve Lilly’s mirikizumab for ulcerative colitis

FDA won’t approve Lilly’s mirikizumab for ulcerative colitis

The FDA has issued a complete response letter to Eli Lilly, turning down its attempt to get approval for anti-IL-23p19 antibody mirikizumab as a treatment for ulcerative c

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FDA advisors split on Biogen’s ALS therapy

FDA advisors split on Biogen’s ALS therapy

But unanimous vote on biomarker validity could support accelerated approval of tofersen.

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MHRA unveils big shakeup in UK clinical trials regs

MHRA unveils big shakeup in UK clinical trials regs

Reforms will make applications streamlined and flexible without affecting safety, says agency.

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GSK wins the vote contest in FDA’s RSV vaccine panels

GSK wins the vote contest in FDA’s RSV vaccine panels

Advisory committee votes unanimously that RSVPreF3 shot is effective, and 10-2 on safety.