FDA advisory panel
Coverage of FDA advisory panel in the Nexus archive.
- What would it take to get peptides on the shelf?
An FDA advisory panel recently approved some popular peptides, drawing significant market attention and raising concerns about the unregulated supply.
- What would it take to get peptides on the shelf?
An FDA advisory panel voted to approve certain peptides, increasing market attention and raising concerns about their unregulated supply.
- FDA advisory panel backed Replimune's twice-rejected melanoma treatment in 10-3 vote
The FDA advisory panel supported Replimune's melanoma treatment RP1 in a 10-3 vote, increasing its chances of approval before the Aug. 2 deadline. RP1 is an engineered viral immunotherapy previously rejected by the FDA.
- STAT+: Pharmalittle: We’re reading about an FDA panel and peptides, a Merck license for an HIV pill, and more
An FDA advisory panel recommended allowing compounding pharmacies to produce peptides like BPC-157 and TB-500, despite FDA staff concerns about safety and efficacy. Sanofi's long-acting insulin pen, Lantus Solostar, faces supply shortages due to increased demand, causing challenges for diabetes patients.
- FDA advisory panel recommends loosening restrictions on 2 unapproved peptides
An FDA advisory panel recommended easing restrictions on certain unapproved peptides, which are short chains of amino acids that can help regulate a variety of functions in the body. CBS News correspondent Adam Yamaguchi reported the development.
- FDA panel recommends mRNA flu vaccine for older adults
An FDA advisory panel unanimously recommended Moderna’s mRNA-based flu vaccine, mFlusiva, for approval in adults aged 50-64 and 65+. The panel voted 9-0 that the benefits outweigh the risks for the vaccine.