US FDA mandates label updates on CAR-T cancer therapies
The health regulor has required related updates to other sections of the label such as warnings and precautions
US FDA finds new manufacturing lapses at Eli Lilly plant
Lilly said in a statement that tirzepatide, the active ingredient in Mounjaro and Zepbound, was not manufactured at…
US FDA approves Pfizer’s blood cancer therapy
Elrexfio will be sold in the United States at a list price of $7,556 and $13,051 for the…
US FDA declines to approve Amneal Pharma’s Parkinson’s drug
Shares of Amneal Pharmaceuticals fell 13.1% to $2.7 in choppy after-market trading
US FDA approves Pfizer’s hair loss drug
The FDA's decision makes Litfulo the first to be allowed for the treatment of the condition in adolescents
US FDA halts Sun Pharma’s trials on dermatological drug
The company said it would work closely with the US FDA to address the agency's concerns, which the…