Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.

Lexicon gets broad indication across heart failure for its dual SGLT1/2 inhibitor, which will be positioned against Lilly/BI’s Jardiance and AstraZeneca’s Farxiga.

VITROS COVID-19 tests from Ortho-Clinical Diagnostics have been cleared by the US FDA, establishing regulatory pathway for future similar tests.

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.