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...
An FDA January inspection at Bioiberica (Barcelona, Spain) leads to a five-item Form FDA-483 that cited significant GMP violations at the drug substan...
CBER updates its prioritization schedule for the remainder of 2022 to account for Covid-19-related work, while it plans to return to normal operating ...