Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.

Upcoming transition in HHS drug pricing policy staff reinforces the Trump Administration's shift away from the 2018 "Blueprint” and towards engaging with bipartisan Congressional legislation – and spotlighting executive action as coming from the White House in the context of the upcoming Presidential campaign.

US FDA's advisory committee review of Gilead’s Descovy for pre-exposure prophylaxis of HIV wasn’t exactly free of controversy. But the meeting sure went more smoothly than the first PrEP review seven years ago.

President Trump isn’t going to let the Democrats own the drug pricing debate heading into the 2020 elections, so biopharma companies can look forward to many more headlines like the importation announcement on 31 July. When will it end?

Senate Finance drug pricing bill is moving forward, with two critical amendments defeated by 14-14 tie votes. One would have stripped the inflation penalty from the bill, which probably would have killed any bipartisan momentum. The second targeted the Medicare Part B International Pricing Index and was defeated by a truly surprising set of votes.