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US FDA mandates label updates on CAR-T cancer therapies
19 April 2024 9:37 AM GMTThe 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
20 Jan 2024 10:16 AM GMTLilly said in a statement that tirzepatide, the active ingredient in Mounjaro and Zepbound, was not manufactured at the Branchburg plant
US FDA approves Pfizer's blood cancer therapy
15 Aug 2023 3:32 PM GMTElrexfio will be sold in the United States at a list price of $7,556 and $13,051 for the 44 mg and the 76 mg vial, respectively, Pfizer said
US FDA declines to approve Amneal Pharma's Parkinson's drug
4 July 2023 7:57 AM GMTShares of Amneal Pharmaceuticals fell 13.1% to $2.7 in choppy after-market trading
US FDA approves Pfizer's hair loss drug
24 Jun 2023 7:58 AM GMTThe 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
2 May 2023 11:31 AM GMTThe company said it would work closely with the US FDA to address the agency's concerns, which the drugmaker expected to be communicated within the...