Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

Pink Sheet infographic details the district court judges and circuit courts that will be deciding the cases brought by industry against the IRA, breaking down the Democrat and Republican appointees as well as the arguments in each suit.

The Class of ’26 of Medicare Price Negotiation University is now on stage. Our infographic profiles who they are and where they come from, breaking down the $50.5B in gross annual Part D spending, about 20% of the total.

The Class of ’26 of Medicare Price Negotiation University is now on stage. Our infographic profiles who they are and where they come from, breaking down the $50.5B in gross annual Part D spending, about 20% of the total.

For the Pepaxto appeal to be wrapped up on a faster timeline than Genentech’s dispute with the US FDA drugs center over Avastin’s breast cancer claim, CBER Director Peter Marks, the commissioner’s designee, would have to render a final decision before January 2024.