FDA warns Invigtrx Therapeutics about 17 deficiencies in its processing of products for allogeneic use.
Mallinckrodt completes a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorenal syndrome Type 1.
CME America recalls its BodyGuard Microset Infusion Sets due to potential medication flow restrictions.
Due to coronavirus concerns, FDA temporarily postpones all domestic routine surveillance facility inspections due to agency staff and company personne...
FDA says a guidance on conducting clinical trials during the Covid-19 pandemic takes effect immediately.
The DC Circuit Court of Appeals rules against FDA in a suit challenging the agencys denial of orphan drug exclusivity for Eagles Bendeka.
Two drug trade associations suggest ways FDA could improve a draft question-and-answer guidance on pediatric study plans for oncology drugs.