Revlimid Cleared For Multiple Myeloma; Celgene Focuses On Thrombotic Risk
Celgene hopes to submit data to FDA showing that thromboembolic risks linked to Revlimid (lenalidomide) can be reduced with prophylactic anticoagulant use
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FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials