
Polivy adcom: no overall survival, no problem
A US adcom surprisingly backs Polivy’s front-line use, and blockbuster sales could follow.

US deal watchdog's bark could be worse than its bite
Chills in the biopharma M&A market are frequently blamed on the FTC. But is the agency really stopping deals from happening?

A year of two halves for US approvals
FDA green lights picked up in the second half, but for the really impressive number look at year-five sales.

Regulatory developments over the Christmas period
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.

An expensive new haemophilia gene therapy hits the US
The approval is good for CSL, and better for Uniqure.