FDA is encouraging manufacturers of marketed but unapproved drugs to voluntarily submit applications by highlighting the possibility of a de facto exclusivity period for sponsors who receive NDA approval for a drug that other firms are marketing without approval

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

The recently US FDA-cleared Velys robotic-assisted system from DePuy Synthes has distinct features. It also has a small footprint that makes it well-suited for ambulatory surgery centers. See what Larry Biegelsen, an analyst with Wells Fargo, said about it here.