FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMist Quadrivalent, a ne...
Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated Products.
Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Providers Regarding Scienti...
FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine learning-enabled medical...
FDA says Embryll Life Sciences is illegally marketing Lanomax, an unapproved animal drug intended to treat cataracts in animals.
FDA clears an NK Gen IND trial for its Alzheimers disease cell therapy.
FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (CB03) for treating am...
FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defi...
