US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).
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Keeping Track: Orphan Drugs Aplenty At US FDA, From Pyrukynd Approval To Adagrasib Standard Review
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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.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.