Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makary’s initiatives following his resignation.
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for the investigational Huntington's disease gene therapy.
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makary’s initiatives following his resignation.
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for the investigational Huntington's disease gene therapy.
FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular age-related macular degeneration.
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in generic prostate cancer bicalutamide tablets produced by Intas and Sun at facilities in India.
