An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (delandistrogene moxeparvov...
Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platforms due to concerns ab...
FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.
FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...
FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.
SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.
FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.
Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...
