Pfizer and BioNTech announce results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses for a lower-...
FDA sends Verrica Pharmaceuticals a complete response letter on its NDA for VP-102 for treating the skin disease molluscum contagiosum.
FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-related macular degenerat...
Federal Register notice: FDA makes available on its Web site certain final administrative orders, including for over-the-counter (OTC) drug monographs...
FDA issues an alert about the potential for false positive results with Abbott Moleculars Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP K...
AbbVie files a BLA supplement for Skyrizi (risankizumab-rzaa) for treating patients 16 years and older with moderate to severe Crohns disease.
FDA Review posts the Federal Register notices for the week ending 9/17/2021.