Advisory Committee
FDA advisory committees rule in favor of Rexulti for agitation associated with Alzheimer’s
Two FDA advisory committees voted in favor of a supplemental new drug application for Rexulti, ruling there was sufficient data to show treatment for agitation associated with Alzheimer’s dementia outweighed the risks.
FDA advisory committee votes for potential accelerated approval of tofersen for SOD1-ALS
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that tofersen, an antisense oligonucleotide for the treatment of superoxide dismutase 1 ALS, may be considered for potential accelerated approval.
FDA will not hold advisory committee meeting on zuranolone NDA
The FDA announced it does not plan to hold an advisory committee meeting on Sage and Biogen’s new drug application for zuranolone to treat major depressive disorder and postpartum depression in adults.
FDA committees take steps to making Narcan available over the counter
On Wednesday, two FDA advisory committees unanimously voted in favor of Narcan nasal spray being made available as an over-the-counter emergency treatment for opioid overdose.
FDA committee endorses plan to simplify COVID-19 vaccines
An FDA advisory committee voted unanimously Thursday in favor of a plan to streamline and simplify COVID-19 vaccine compositions in the United States by replacing initial, primary doses with the bivalent vaccines currently used as boosters.
FDA committee recommends approval of rezafungin for candidemia and invasive candidiasis
The FDA Antimicrobial Drugs Advisory Committee voted on Wednesday 14-1 in favor of the use of rezafungin for the treatment of candidemia and invasive candidiasis.
HHS announces 2025 Dietary Guidelines Advisory Committee members
The HHS has announced the 20 selected members of the 2025 Dietary Guidelines Advisory Committee, which will inform nutritional guidelines for Americans over the next half-decade.
FDA committee votes in favor of Xphozah for phosphate control in patients on dialysis
An FDA advisory committee voted 9-4 in favor of the use of Xphozah as a monotherapy for controlling serum phosphorus levels in adults with chronic kidney disease on dialysis.
FDA panel: Pulse oximeters show clear ‘disparate performance’ for darker skin pigmentation
At a Medical Devices Advisory Committee meeting held Nov. 1, panelists recommended improvements to the FDA regarding pulse oximeters and their accuracy among patients with darker skin pigmentation.
CDC committee recommends adding COVID-19 vaccine to childhood immunization schedule
The CDC’s vaccine advisory committee voted Thursday to approve the addition of COVID-19 vaccines to the recommended childhood immunization schedule.