The House of Representatives fails to pass HR 5247, the Right to Try Act of 2018, under suspension of the rules.
FDA warns Frances Quali-Controle contract laboratory about CGMP violations in producing finished pharmaceuticals.
The Presidents Cancer Panel says FDA can have a role in helping to address the rapid increase in cancer drug cost.
FDA clears a CereMetrix 510(k) for its neuroimaging analytics and quantification platform CereMetrix Silver.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is prog...
Stakeholders tell FDA ways it could improve a draft guidance on the least burdensome concept for medical device regulation.
FDA places on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZenecas Imfinzi (durvalumab) for trea...
FDA warns Laser Dental Innovations about Quality System violations in its manufacturing of dental handpieces and laser fiber optic surgical devices.