FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular ...
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignation.
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...
A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing document revealing ...
FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modifications.
FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devic...
FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufacturing of over-the-c...
North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated companies.
