The Trump ad­min­is­tra­tion is push­ing the FDA to ce­ment the de­tails be­hind its proac­tive pub­lic re­lease of re­jec­tion let­ters sent to phar­ma com­pa­nies.

The rule­mak­ing...

There's an an­swer emerg­ing on the multi­bil­lion-dol­lar ques­tion of whether the Trump ad­min­is­tra­tion's gut­ting of FDA staff in April 2025 would slow down drug ap­provals...

Act­ing FDA CDER di­rec­tor Michael Davis has pro­mot­ed a long­time FDA staffer as an act­ing deputy di­rec­tor at the drug cen­ter.

Lisa Yanoff, an agency...

A pro­posed rule would cut the rates by which Medicare pays hos­pi­tals for 340B drugs by more than a third, re­viv­ing a sim­i­lar pol­i­cy in­tro­duced...

An FDA warn­ing let­ter sent late last month to Gen­zyme's Ire­land-based man­u­fac­tur­ing site, now owned by Sanofi, rais­es sig­nif­i­cant qual­i­ty- and da­ta-re­lat­ed is­sues.

On da­ta...

The FDA gave the go-ahead to Or­ca Bio’s T cell ther­a­py that would re­duce trans­plant-re­lat­ed com­pli­ca­tions for blood can­cer pa­tients.

The ther­a­py will be brand­ed...