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...
FDA updates a Class 1 recall notice involving Woodside Acquisitions Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Ra...
Federal Register notice: FDA sends to OMB an information collection extension entitled Food Labeling: Notification Procedures for Statements on Dietar...
Federal Register notice: FDA submits to OMB an information collection extension entitled Tropical Disease Priority Review Vouchers.
GSK announces positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the companys respiratory syncyti...