FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating cataplexy or excessi...
FDA publishes six-month summary statistics for drug development tool qualification projects.
FDA says healthcare professionals should discuss naloxone with patients taking opioid pain medicines or drugs for opioid use disorder and consider pre...
Fresenius Kabi recalls two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount of lidocaine present...
FDA and the Federal Trade Commission says Create Wellness Clinics is marketing several types of unapproved products intended to treat Covid-19.
Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Bas...
A Lassman Law & Policy petition asks FDA to require substantial evidence of effectiveness before approving a BLA for Mesoblasts Ryoncil.
CDER accepts a C-Path qualification plan for glutamate dehydrogenase as a safety biomarker for drug-induced liver injury.