Clarus Therapeutics Inc. was looking for the endorsement of a key member of the US FDA Bone, Reproductive, and Urologic Drugs Advisory Committee for its novel oral testosterone replacement therapy.
US FDA Approval Climate: What Do The Oral Testosterone Reviews Tell Us?
Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go in approving new entrants to a market with widespread historic off-label use and CV risks.
