FDA moves aggressively on low-T drugs, but replacement pill still aims to enter market

Last week the FDA cracked down hard on low-T therapies. Its expert panel voted to advise the agency to restrict the use of such drugs for a specific medical need. And a majority wanted cardiovascular studies to assess age-related risks. Then the agency voted to reject Clarus Therapeutics' Rextoro, which was aiming to become the first oral therapy in a market dominated by gels. This week Lipocine is talking up the Phase III results of its testosterone replacement pill, but the timing is downright horrible, given the agency's turn against the market generally. Story | More

Suggested Articles

Adamis Pharmaceuticals' EpiPen contender Symjepi, which was rejected last year before the EpiPen havoc, won approval from the FDA.

Researchers in the U.K. have developed a technique to better predict results in liver cancer when drug-laden polymer beads are used to deliver medicines.

It’s not exactly going to be smooth sailing for Allergan’s multidose bottle version of dry-eye med Restasis. As it finally gets the green light from the FDA, a…