Safety

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FDA rejects Amgen/UCB osteoporosis drug

The FDA has rejected Amgen and UCB’s Evenity (romosozumab) osteoporosis drug after a late-stage trial unexpectedly highlighted a potential cardiac safety risk.

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Biogen MS drug hit by EU safety restriction

Regulators concerned over liver damage risk

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Endo gives way and withdraws opioid painkiller after FDA pre...

Pharma makes decision after FDA intervenes to fight opioid crisis.

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Seattle Genetics halts trials of latest ADC after safety war...

Monitoring committee concerned about high death rates.

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Novo hopes data will boost new insulin in US and Germany

Novo Nordisk hopes that new data supporting the cardiovascular and glycaemic safety of its Tresiba long-acting insulin will prove a game-changer in the US.

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