Keeping Track: FDA Approves Two Novel Orphan Drugs; Breakthrough Applications Keep Agency Busy
The latest drug development news and highlights from our FDA Performance Tracker.
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Breakthrough's Achilles Heel: Alexion’s Newly Acquired Kanuma Delayed By Manufacturing
FDA extends the PDUFA date for enzyme replacement therapy by three months so agency can review chemistry, manufacturing and controls information; another drug, Strensiq, is also pending at FDA without any action.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
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.