FDA Advisory Panel Generally Pleased With Pulse Oximetry Clinical Trial Proposal
An FDA advisory committee gave generally high marks to the agency’s latest effort to improve the accuracy of pulse oximeters when used in darker-skinned patients, but raised questions about some of the FDA’s proposed premarket clinical trial guidance for pulse oximeter manufacturers. “I really applaud the efforts of the FDA to reduce disparate bias in […]
FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]
FDA Panel Gives Strong Backing to RSV Vaccine for Protecting Infants
An FDA panel on Thursday gave a strong endorsement for what could become the first maternal respiratory syncytial virus (RSV) vaccine approved for protecting infants against the annual scourge. In a unanimous vote, all 14 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said that the available data support the efficacy of […]
FDA Greenlights New First-Line Regimen in Bladder Cancer
The FDA gave accelerated approval to enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) as first-line treatment for certain patients with locally advanced or metastatic urothelial cancer, the agency announced on Monday. Specifically, the combination is indicated for those who are ineligible for cisplatin-containing chemotherapy, and the approval marks the first anti-PD-1/antibody-drug conjugate combination for this patient […]
Alzheimer’s Aducanumab Prescribing Information Changes
Just a month after it gave the new Alzheimer’s drug aducanumab (Aduhelm) the green light, the FDA decided to change the label. The agency approved an updated label narrowing who should receive the drug, stating that aducanumab should be initiated in Alzheimer’s patients with “mild cognitive impairment or mild dementia stage of disease, the population […]