ImmunityBio refiles its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unresponsive non-musc...
Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurre...
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...
