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The FDA on Monday only granted Liquidia’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.
Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina.
The global contract development and manufacturing organization is investing $1.2 billion to boost production capabilities at its Holly Springs, North Carolina, site including mammalian cell culture bioreactors.
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
Eli Lilly and Company announced plans to build a new manufacturing plant in Concord, North Carolina.
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