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.
FDA grants Amadix a breakthrough device designation for PreveCol, a blood test for early detection of colorectal cancer.
FDA grants fast track designation to an investigative Kyverna CAR-T drug to treat some patients with multiple sclerosis.
