FDA asks a Texas federal court to reject an Association for Hippocratic Medicine request for a preliminary injunction to overturn the agencys approval...
Moderna says it will seek regulatory approval for an investigational mRNA RSV vaccine for use in older adults.
SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals, and it is planning to fil...
The Government Accountability Office says HHS could improve its oversight of research involving enhanced potential pandemic pathogens.
The CDER Office of Pharmaceutical Quality says its two Quality Management Maturity pilots provided insights into how better to develop and implement a...
Federal Register notice: FDA announces a 3/28-29 a joint advisory committee meeting to discuss proposed changes to the isotretinoin iPLEDGE Risk Evalu...
Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the viral safety of bio...
Federal Register notice: FDA issues an order permanently debarring Gabriel J. Letizia, Jr from providing services related to an approved or pending dr...
