Home » FDA Tells BMS to Fix Manufacturing Before it Grants BLA Approval
FDA Tells BMS to Fix Manufacturing Before it Grants BLA Approval
November 2, 2010
The FDA has told Bristol-Myers Squibb (BMS) that it will not approve the company’s BLA for transplant drug Nulojix (belatacept) until it resolves manufacturing issues at a Manati, Puerto Rico, facility.
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