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FDA still sceptical about Intercept’s NASH drug

Intercept Pharma’s hope that its OCA candidate could become the first FDA-approved drug to treat non-alcoholic steatohepatitis (NASH) is starting to look decidedly faint.

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FTC lawsuit against Amgen sends shiver through pharma

Rumours that the US financial regulator is planning to block Amgen’s $28 billion takeover of Horizon Therapeutics have turned out to be true, and the industry is now scram

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Reports say FTC is planning to block Amgen’s Horizon deal

Shares in Horizon Therapeutics have been in sharp decline after reports emerged that the US financial regulator is preparing a challenge to its $28 billion takeover by Amg

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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

The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as di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

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

FDA still sceptical about Intercept’s NASH drug

FTC lawsuit against Amgen sends shiver through pharma

Reports say FTC is planning to block Amgen’s Horizon deal

FDA rejects ImmunityBio’s bladder cancer drug

FDA sets out its thinking on decentralised clinical trials

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

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