FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx, have been recalled.
Attorney Kurt Karst says Congress is considering drug pricing legislation that is opposed by the Association for Accessible Medicines and could lead t...
BIO president Jim Greenwood says the administration and House Democrats have surrendered a powerful tool to protect American biotechnology companies i...
Sens. Grassley and Warren ask FDA when draft OTC hearing aid regulations will be published
Verax Biomedical calls on FDA not to take actions that would be considered arbitrary and capricious if unsupported by additional scientific evidence o...
The Alliance for Cell Therapy Now calls on FDA and other agencies to act to measure outcomes related to regenerative cell therapies.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rempex Pharmaceuticals Vabomere (vaborbactam an...
Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Designated New Animal Drugs for Minor Use ...