Federal Register notice: FDA makes available a final guidance entitled Benefit-Risk Assessment for Human Drug and Biological Products.
FDA approves a Shockwave Medical PMA for what the company calls an enhanced Shockwave C2+ Coronary Intravascular Lithotripsy catheter.
Federal Register notice: FDA releases a final guidance entitled Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies;...
FDA approves Pfizers Penbraya (meningococcal groups A, B, C, W and Y vaccine), a pentavalent vaccine that protects against the most common serogroups ...
Philips Respironics recalls its V60 Ventilators and V60 Plus Ventilators because the devices contain power management printed circuit board assemblies...
The U.S. government arrests a Chinese citizen related to a criminal complaint about manufacturing and distributing misbranded medical devices and maki...
FDA approves a BioMarin Pharmaceutical supplemental NDA for Voxzogo (vosoritide) to increase linear growth in pediatric patients with achondroplasia w...
Federal Register notice: FDA withdraws approval of eight ANDAs after the applicants notified the agency that they were no longer marketed.
