The firm expects its $1.25 billion cash runway to cover operating and capital expenses through 2029, including development plans for key assets.

The agency is asking the firm to conduct a new study, which Pierre Fabre says is "a significant and unexpected change" from prior discussions.

The agency outlined the adjustments it's willing to make to "remove barriers and perceived misconceptions" for innovative medicines.

Genetic counselors are trying once again to gain Medicare recognition through this bill, so they can bill for their services.