The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the ...
The FDA has approved an oral combination therapy for certain adults with newly diagnosed acute myeloid leukemia.Decitabine ...
On May 13, the Food and Drug Administration (FDA) approved decitabine and cedazuridine (Inqovi) tablets in combination with ...
Many of us assume that the US Food and Drug Administration approves all of our personal care products, vetting every serum, supplement, and LED mask. After all, on average, people slather on six to 12 ...
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
The FDA approved a peptide for a rare mitochondrial disease. But what's more interesting is the more common potential use ...
Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...
A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and ...