Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.

In the third quarter of 2021, medical device company M&A values reached $7.1bn, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $6.7bn.

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.