FDA grants Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic in cancer treatment.
Supernus Pharmaceuticals refiles its NDA for SPN-812 for treating ADHD in pediatric patients.
FDA urges drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient due to its complex nature that makes it...
FDA grants Ellodi Pharmaceuticals a fast track designation for APT-1011 (fluticasone propionate) oral disintegrating tablet for treating eosinophilic ...
FDA grants TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon for tre...
FDA releases a summary of the 12/17/20 GDUFA reauthorization meeting.
FDA Acting commissioner Janet Woodcock says FDA is developing guidances for developers of Covid-19 diagnostics, therapeutics and vaccines to help guid...
FDA reviewers take issue with a Merck study supporting a new indication for Keytruda (pembrolizumab) for treating patients with high-risk early-stage ...