Advisory Committee
ACIP votes to simplify meningococcal B vaccine recommendations
A CDC advisory committee on Thursday voted unanimously to “harmonize” serogroup B meningococcal vaccine recommendations for healthy adolescents and young adults and children who have a higher risk for infection.
CDC recommends 2nd COVID shot for some, lowering age for pneumococcal vaccination
A CDC advisory committee on Wednesday recommended that adults aged 65 years or older and anyone who is at least moderately immunocompromised receive a second dose of COVID-19 vaccine this season.
Prevention and Treatment
FDA advisory panel votes against Ocaliva for PBC citing ‘concern for real possible harm’
An FDA advisory committee voted against approval for obeticholic acid in primary biliary cholangitis without cirrhosis or compensated cirrhosis with portal hypertension, citing “concern for real possible harm”.
FDA rejects MDMA-assisted PTSD therapy, requests additional data
The FDA on Aug. 9 issued a complete response letter to Lycos Therapeutics for its new drug application regarding midomafetamine capsules for the treatment of PTSD, citing insufficient data to approve and requesting an additional phase 3 trial.
FDA advisory committee backs donanemab for early-stage Alzheimer’s
An FDA advisory panel on Monday voted in favor of donanemab as a treatment for early symptomatic Alzheimer’s disease.
'It just needs to be better studied': FDA advisory committee rejects MDMA for PTSD
An FDA advisory committee voted against recommending a psychedelic treatment for PTSD, citing insufficient data for what many described as a still-promising path forward.
FDA panel backs Guardant’s colorectal cancer blood test for favorable risk-benefit
An FDA advisory committee has voted strongly in favor of approval for Guardant Health’s blood test for colorectal cancer, intended for patients aged 45 years and older at average risk for disease.
FDA panel: Proposed changes to pulse oximeter premarket studies generally well received
At a Medical Devices Advisory Committee meeting held Feb. 2, proposed changes to premarket studies assessing pulse oximeter performance were generally well received by the panelists.
Sickle cell gene therapy ‘benefits far outweigh the risks,’ FDA adviser says
An FDA panel appeared comfortable with theoretical safety concerns during an advisory committee meeting considering the risks vs. benefits of what would be the first gene therapy for the treatment of sickle cell disease.