FDA clears a BrightHeart 510(k) for the B-Right Views, an artificial intelligence-powered tool that automatically detects the standard views required ...
The Government Accountability Office tells HHS secretary Robert F. Kennedy, Jr., about priority recommendations it has made in the past to improve FDA...
FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics.
Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exercise capacity in pati...
FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) for treating Hunter s...
FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for significant GMP viola...
FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.
FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.
