In February 2015, Pfizer's Ibrance (palbociclib) was granted accelerated approval by the FDA for treatment of newly diagnosed HR+ (hormone receptor positive) / HER2- breast cancer in post-men
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh