FDA advisory committee
FDA Advisory Committee Supports Nirsevimab to Prevent RSV in Infants
The FDA Antimicrobial Drugs Advisory Committee endorsed the safety and efficacy of an experimental ...
JUNE 9, 2023
Medicare to Restrict Aducanumab Coverage
CMS has announced a preliminary National Coverage Determination restricting Medicare coverage of the ...
JANUARY 13, 2022
FDA Grants New Indication for Descovy for PrEP
Descovy for PrEP is indicated to reduce the risk for sexually acquired HIV-1 infection in adults and adolescents ...
OCTOBER 3, 2019
FDA Advisory Committee Split Over Approval for Zynquista
FDA advisory committee was divided about whether the overall benefits of Zynquista to treat adults with type 1 ...
JANUARY 18, 2019
Tafenoquine Gets FDA Advisory Committee Nod for Approval
The FDA Antimicrobial Drugs Advisory Committee today voted to recommended approval of GSK's tafenoquine for the ...
JULY 12, 2018
FDA Advisory Committee Fails to Recommend Approval of Hydexor
Coupled with concern over the opioid epidemic, the committee was not convinced that the product's efficacy in ...
FEBRUARY 15, 2018
Plivensia Rejected by FDA to Treat Rheumatoid Arthritis
The FDA Arthritis Advisory Committee has voted to deny the Biologics License Application approval of Johnson & ...
AUGUST 11, 2017
FDA Advisory Committee Gives Solithromycin Mixed Review
The committee was concerned about hepatic toxicity, as well as providers using the agent outside its indication ...
NOVEMBER 4, 2016
New Abuse-Deterrent Opioid One Step Closer to Approval
An FDA committee recommended approval of Vantrela ER, a hydrocodone ER tablet with abuse-deterrent capabilities.
JUNE 8, 2016
