FDA asks manufacturers of generic Accutane to update the drugs labeling.
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 t...
FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and ...
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.
