Advisory Committee
FDA advisory committee votes to support approval of ALS therapy
Amylyx Pharmaceuticals announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted to support approval of the company’s oral, fixed-dose therapeutic AMX0035 for the treatment of ALS.
CDC recommends bivalent COVID-19 boosters
The CDC’s vaccine advisory committee on Thursday voted to recommend the bivalent COVID-19 booster vaccines authorized this week by the FDA that also target the omicron variant of SARS-CoV-2.
ACIP votes to recommend Novavax COVID-19 vaccine for US adults
The CDC’s vaccine advisory committee on Tuesday voted to recommend Novavax’s two-dose COVID-19 vaccine for adults in the United States.
FDA advisors vote in favor of adding omicron to COVID-19 boosters
An FDA advisory committee voted Tuesday to recommend changing the composition of COVID-19 booster vaccines to include the addition of the omicron variant of SARS-CoV-2 as a component.
FDA committee unanimously endorses gene therapy for cerebral adrenoleukodystrophy
Biotechnology company bluebird bio announced that an FDA advisory committee has unanimously endorsed its gene therapy treatment for early active cerebral adrenoleukodystrophy.
Top in ID: New Paxlovid data; updates to flu, MMR, pneumococcal vaccinations
A recent study showed that Paxlovid was associated with a 46% reduction in severe COVID-19 or death among high-risk patients. It was the top story in infectious disease last week.
FDA committee recommends COVID-19 vaccines for youngest children
An FDA advisory committee on Wednesday unanimously recommended that Moderna and Pfizer-BioNTech’s COVID-19 vaccines be authorized for children as young as 6 months old.
FDA committee unanimously backs Moderna vaccines for children, adolescents
An FDA advisory committee on Tuesday unanimously backed Moderna’s COVID-19 vaccines for children and adolescents aged 6 to 17 years.
FDA committee recommends EUA for Novavax’s COVID-19 vaccine
An FDA advisory committee on Tuesday recommended that Novavax’s two-dose COVID-19 vaccine be made available in the United States under an emergency use authorization.
CDC committee recommends COVID-19 booster for kids aged 5 to 11 years
The CDC’s vaccine advisory committee voted Thursday to recommend that children aged 5 to 11 years receive a booster dose of the Pfizer-BioNTech COVID-19 vaccine.