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FDA reviewer pokes holes in Geron’s MDS drug data

Geron could have a tougher time than it anticipated at tomorrow’s FDA advisory committee meeting for myelodysplastic syndromes (MDS) drug candidate imetelstat.

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FDA clears Wegovy’s label to include heart health benefits

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese.

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Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, del

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Minerva slumps as FDA finds fault with schizophrenia filing

Shares in Minerva Neurosciences have lost more than half their value after the FDA rejected its marketing application for roluperidone as a treatment for the negative symp

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Interchangeable high-concentration Humira approved in US

For the first time, pharmacists in the US will be able to substitute a cheaper biosimilar version when they receive a prescription for AbbVie’s high-concentration formulat

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