Four Major Approval Decisions To Watch Out For In Q2
Having looked at four prominent drug candidates which are expecting important top-line data this quarter, with the help of Biomedtracker's Q2 Outlook Report, we take a look at four other assets that could soon break into the US market, from infectious diseases to diabetes.
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Citing numerous concerns about design of the Phase II CENTAUR trial and statistical robustness of the results, agency reviewers question whether a single study provides substantial evidence of efficacy for approval of AMX0035.
The latest news about applications under FDA review, from the Pink Sheet’s US FDA Performance Tracker