CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

A few cases of COVID-19 relapse have Twitter abuzz about the need for data on Paxlovid’s effectiveness, particularly against the Omicron variant and in vaccinated individuals. Despite regulatory approval in India, the drug has not yet been included in treatment guidelines and a debate on recommended dosage now complicates matters

The Danish diabetes titan teams with Moderna’s founder on cardiometabolic R&D. Troubled cell therapy biotech Bone Therapeutics negotiates reverse merger with Medsenic.

Medtech Insight caught up again with iRhythm CEO Quentin Blackford about his vision for the company as it plans for the next five to ten years of expansion in the remote cardiac monitoring and arrhythmia diagnostics market.