Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries call on Congress to hold a hearing to understand the agencys app...
FDA publishes an updated guidance incorporating GDUFA 3 performance goals on amendments and requests for final approval to tentatively approved ANDAs.
FDA sends Theratechnologies a complete response letter on its supplemental BLA for an F8 formulation of Egrifta SV (tesamorelin), indicated for reduci...
Federal Register notice: FDA sends to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis...
Federal Register notices: FDA posts four announcements about a priority review voucher being redeemed as part of a product approval.
CDRH says its Office of Strategic Partnerships and Technology Innovation has been elevated to a super office.
A Lilly subsidiary says its investigational gene therapy for some genetic hearing loss showed positive results in a Phase 1/2 trial.
Haleon recalls eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to microbial contamination concerns.
