Thumbs Down From FDA Panel on Plastic Meniscus Replacement
An FDA advisory committee voted 6-2, with one absention, that a novel, synthetic knee meniscus replacement’s benefits do not outweigh its risks, and thus is not suitable for marketing. Members of the Orthopaedic and Rehabilitation Devices Panel of the FDA’s Medical Devices Advisory Committee said the efficacy data were too weak, and a nearly 50% […]
FDA Advisors Endorse Rexulti for Agitation in Alzheimer’s Dementia
FDA advisors voted in favor of brexpiprazole (Rexulti) for treating agitation associated with Alzheimer’s dementia (AAD), despite increased mortality risk. By a vote of 9-1 on Friday, members of the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) and the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) said the data presented by the drug’s sponsors, […]
Do Away With ‘Lockout’ Period in iPLEDGE, FDA Advisors Urge
An FDA advisory committee on Wednesday voted 17-4 (with one abstention) to recommend removing a “lockout period” from a risk evaluation and mitigation strategy (REMS) for isotretinoin prescribing that requires patients to wait an extra 19 days — and take an additional pregnancy test — if they miss a 7-day window for picking up their […]
FDA Panel Supports Tofersen for Rare Genetic ALS
A panel of FDA advisors voted unanimously that plasma neurofilament light chain (NfL), a biomarker of neurodegeneration, is a reasonable surrogate endpoint in amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene (SOD1-ALS). In a 9-0 vote on Wednesday, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee said the available […]
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say
An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of […]
CDC Panel Backs Novavax COVID Vaccine for Adults
The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Novavax’s COVID-19 vaccine for individuals 18 and up. With a vote of 12-0, the advisory panel endorsed a two-dose primary series of the adjuvanted, protein-based vaccine, which will be administered 3 weeks apart. The recommendation follows FDA’s emergency use authorization last week. Shortly […]
FDA Panel Gives Thumbs Up to Omicron-Containing COVID Boosters
An FDA advisory committee voted 19-2 on Tuesday to recommend use of an Omicron-specific component in a future COVID-19 vaccine booster. “We really do need vaccines that provide broader protection against variants that have not yet emerged,” said Melinda Wharton, MD, MPH, associate director of vaccine policy at the CDC, at a remote meeting of […]
ACIP Backs Moderna’s COVID Shot for Kids 6-17 Years
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine. With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The […]
CDC’s Advisers Endorse COVID Vaccines in Youngest Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Saturday to recommend that children 6 months and older receive COVID-19 vaccines. As proposed by CDC staff, and now approved by CDC Director Rochelle Walensky, MD, MPH, the recommendations call for a two-dose series of Moderna’s product for children ages 6 months to 5 […]
Rep. Cori Bush: Biden Should ‘Absolutely’ Say The Word ‘Abortion’ More
WASHINGTON ― As the Senate voted on safeguarding abortion rights Wednesday, a group of House Democrats were there urging their colleagues to vote yes. The Women’s Health Protection Act, which would have created federal protections for providing and accessing abortion services, failed along party lines ― with the exception of West Virginia’s Joe Manchin, the […]