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A February inspection at Rentschler Biopharmas German drug substance manufacturing plant results in a nine-item FDA-483 that cites...[ Price : $8.95]
While FDA extends its own NDA review, Health Canada approves Amylyx Pharmaceuticals Albrioza (sodium phenylbutyrate and ursodoxico...[ Price : $8.95]
FDA clears an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients.[ Price : $8.95]
FDA removes a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phe...[ Price : $8.95]
FDA approves an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia ar...[ Price : $8.95]
FDA updates a Class 1 recall notice involving Woodside Acquisitions Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio S...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Food Labeling: Notification Procedures for ...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension entitled Tropical Disease Priority Review Vouchers...