Federal Register notice: FDA renews its Science Advisory Board to the National Center for Toxicological Research for an additional two years.
A February inspection at Rentschler Biopharmas German drug substance manufacturing plant results in a nine-item FDA-483 that cites significant GMP vio...
While FDA extends its own NDA review, Health Canada approves Amylyx Pharmaceuticals Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) for treati...
FDA clears an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients.
FDA removes a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phenylketonuria after c...
FDA approves an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata.
FDA grants an emergency use authorization for Laboratory Corp. of Americas VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system to aid...
Green Pharmaceuticals recalls one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contamination identified as...