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Lexicon Pharmaceuticals, Inc.

http://www.lexpharma.com/

Latest From Lexicon Pharmaceuticals, Inc.

Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market

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.

US FDA Performance Tracker Approvals

Lexicon’s Sotagliflozin Succeeds In Heart Failure Following Disappointment In 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.

Approvals Business Strategies

Quidel Subsidiary Lands First De Novo Clearance For COVID-19 Serology Tests

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

Regulation Approvals

Keeping Track: Showers Of Approvals In US FDA’s May Forecast

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.

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