FDA grants Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization in treating symptomatic knee osteo...
FDA posts a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.
Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and discuss Pfizer-BioNTe...
FDA approves changes to the isotretinoin iPLEDGE REMS.
Federal Register notice: FDA withdraws three guidance documents on hand sanitizer products because consumers and healthcare personnel are no longer ex...
FDA approves a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammog...
The FDA Vaccines and Related Biological Products Advisory Committee will consider 10/14 Modernas request for an EUA for a Covid vaccine booster jab.
Some 26 healthcare organizations led by Public Citizen say they oppose the potential nomination of BIO CEO Michelle McMurry-Heath to be FDA commission...