How 2 FDA citations complicate Hengrui, Elevar's push for liver cancer combo approval

Hengrui Pharmaceuticals and Elevar Therapeutics face a second FDA Form 483 citation at a finished drug manufacturing facility in Lianyungang, complicating their fourth attempt to win approval for camrelizumab and rivoceranib, a liver cancer combination already rejected three times. The second citation arrived late in the review cycle and was not mentioned in the July CRL, but must be resolved before approval is possible.

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