FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.
FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.
Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.
FDA warns Hialeah, FL-based physician Peter Michael about failing to follow the investigation plan in two clinical studies.
FDA gives accelerated approval to Regenerons Lynozyfic for some multiple myelomas.
FDA warns Hoffman Estates, IL-based InVia Fertility Specialists about multiple violations of regulations governing human cells, tissues, and cellular ...
FDA warns Indias Healwell Homeo Private Limited about producing adulterated homeopathic and OTC drugs with CGMP violations.
FDA says Contec has issued a software patch that resolves cybersecurity vulnerabilities in certain Contec and Epsimed patient monitors by removing net...
