Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

Pear Therapeutics filed for Chapter 11 bankruptcy in April and sold its remaining assets in an auction for about $6m. The demise of one the pioneers in the prescription digital therapeutics industry highlights the challenges PDT developers face getting their products reimbursed.

The US FDA approved Rexulti as the first drug for agitation in Alzheimer’s disease, a multibillion-dollar market where Lundbeck estimates it could bring in $1bn in annual sales.

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.