Although only half over, 2011 already has been pivotal for hepatitis C drug development, with the launch of two paradigm-shifting protease inhibitors, Johnson & Johnson/Vertex Pharmaceuticals Inc.'s Incivek (telaprevir) and Merck & Co.'s Victrelis (boceprevir). Both hit the market in May, even as attention is now shifting to the next big advance in HCV. Based on its work on next-gen HCV treatment, Pharmasset, Inc. has captivated the investment community.

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.