FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular ...
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.
A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to...
Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating roo...
FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its sterile drug manufacturing...
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.
