The FDA has proposed to withdraw its approval of avacopan for ANCA-associated vasculitis, alleging that employees of the ...

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 has approved an oral combination therapy for certain adults with newly diagnosed acute myeloid leukemia.Decitabine ...

Foundation Medicine previously received companion diagnostic approval for its FoundationOne Liquid CDx assay alongside EMD Serono's Tepmetko.

On May 13, the Food and Drug Administration (FDA) approved decitabine and cedazuridine (Inqovi) tablets in combination with ...

The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up the drug’s 2021 approval for a rare and potentially fatal blood vessel ...

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 ...

The US Food and Drug Administration (FDA) should establish a public database of medical device labels that is accessible to patients, healthcare providers, and consumers. This database would help ...

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...

For manufacturers, medical device companies, and laboratories that use the commercial diagnostic tests they produce, ...

Foundation Medicine, Inc., a global, patient-focused precision medicine company , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne ® CDx ...

A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and ...