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Tolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory approval.

The 185-acre site will be the company’s largest single investment to date, with a focus on small-volume parenteral products like vials and prefilled syringes.

On a conference call, executives claimed that a closely watched breast cancer pill and portfolio of weight loss medicines could bank more than $9 billion annually.