FDA pulls for further consideration a draft guidance on statistical approaches to evaluate analytical similarity between a biosimilar and a reference ...
FDA clears a Tenon Medical 510(k) for the Catamaran Sacroiliac Joint Fixation System, indicated for sacroiliac joint fusion for conditions including j...
FDA approves a Ferring NDA for Nocdurna and denies two petitions asking it not to approve such an NDA.
FDA approves the Senseonics Eversense continue glucose monitor that uses an implanted sensor to continuously measure glucose levels.
CBS Evening News reports a former Purdue Pharma sales persons claim that the company falsely used pseudoaddiction to minimize the harm blockbuster Oxy...
FDA issues Staar Surgical a close-out letter that lifts a Warning Letter dated 5/21/2014, a signal that the company has corrected all issues to the ag...
FDA announces availability of a revised draft guidance on drug user fee waivers, reductions, and refunds.
The DC federal court orders FDA to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer drug Bendeka.