Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene therapy for Duchenne ...
Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clinical trials.
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.
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FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.
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...
