In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just-announced Advisory ...
FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan to identify patient...
FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Services outsourcing facil...
Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.
FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.
FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of SARS-CoV-2; the age...
Amylyx Pharmaceuticals discontinues development of its investigational therapy AMX0035 (sodium phenylbutyrate and taurursodiol) in progressive supranu...
FDA issues an alert after becoming aware that Abiomed sent a letter to customers recommending that certain automated Impella controllers be removed fr...
