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.
FDA warns Mexicos Glicerinas Industriales about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Autolus Therapeutics says FDA has accepted for review its BLA for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cel...
