source
- European regulators withdraw Amgen's Tavneos over questionable dataEuropean regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
- FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviewsThe Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…