Gottlieb says that changes may be coming, but remains firm on current regulations.
Not all drugs are incredible—and sometimes even the incredible ones have weird origins.
EpiPen manufacturer is accused of lax investigation into problems.
Sodium polystyrene sulfonate interferes with many oral drugs and should be dosed separately.
After trials halted, FDA issues warning on off-label use of the drug.
After Mylotarg was taken voluntarily taken off the market, the FDA is giving it a second chance.
Mid Valley Pharmaceutical recalls two drugs.
Why the agency says the approval of Novartis’ new therapy is historic.
New therapies hold great promise—and great danger.
The recall is just the latest in a bacterial contamination scare.