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FDA rejection

This page shows the latest FDA rejection news and features for those working in and with pharma, biotech and healthcare.

After FDA refusal, Takeda builds case for subcutaneous Entyvio

After FDA refusal, Takeda builds case for subcutaneous Entyvio

of treatment, as it tries to recover from the FDA’s rejection of the new drug in December. ... The Japanese drugmaker’s big  setback a few weeks ago – when the FDA decided the data filed in support of the new formulation wasn’t sufficient to

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  • Pharma deals during February 2014 Pharma deals during February 2014

    This follows an FDA rejection due to its risk / benefit profile and demands for a further trial. ... According to Martin Shkreli, founder and CEO: “We also intend to move quickly to pursue FDA approval of Chenodal for CTX.".

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