FDA to hold advisory meeting on SYD-101, myopia drug it declined to approve

The FDA intends to hold an advisory committee meeting on SYD-101, which is being investigated for pediatric myopia but was not approved despite achieving endpoints in a phase 3 trial, according to a press release from Sydnexis. The announcement follows a formal dispute resolution request that Sydnexis sent the FDA after the agency issued its complete response letter opting not to approve SYD-101

Raccontata dahealio.com