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Tuesday brought another setback for MannKind's Afrezza, with the company announcing that Sanofi will stop selling the rapid-acting inhaled insulin effective April 4, thus terminating a licensing deal the companies reached in 2014. Read More
The Senate HELP Committee has scheduled a Jan. 12 hearing to vote on the nomination of Robert Califf as the next FDA commissioner, a committee spokesman told DID. Read More
The FDA has slapped India's Cadila Pharmaceuticals with a warning letter for GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
The head of CDER’s Office of Compliance is removing herself from all substantive policy decisions after her husband became part-owner in a law firm with pharmaceutical clients. Read More