FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in pediatric patients fi...
CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel updates the number of authorized Covid-19 tests and sample collecti...
A Consumer Reports investigative report says FDA showed no urgency in 2018 to take action against a dietary supplement with opioid-like effects.
The Biden administration adds former FDA chief of staff Lauren Silvis to its Covid-19 response team.
Aquestive Therapeutics says that feedback from FDA has put it on a clear path to resubmit its NDA for Libervant (diazepam) Buccal Film for managing se...
FDA grants accelerated approval to Sarepta Therapeutics NDA for Amondys 45 (casimersen) injection for treating exon 45 skipping Duchenne muscular dyst...
Three Hogan Lovells attorneys predict an increase in FDA enforcement action against health-related claims in product labeling.
Panelists at a virtual digital health conference say FDA enforcement discretion in their arena is ambiguous.