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FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMis...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Export Certificates for FDA Regulated ...[ Price : $8.95]
Federal Register notice: FDA posts a revised draft guidance for industry entitled Communications From Firms to Health Care Provide...[ Price : $8.95]
FDA and two international regulatory partners state five guiding principles for predetermined change control plans in machine lear...[ Price : $8.95]
FDA says Embryll Life Sciences is illegally marketing Lanomax, an unapproved animal drug intended to treat cataracts in animals.[ Price : $8.95]
FDA clears an NK Gen IND trial for its Alzheimers disease cell therapy.[ Price : $8.95]
FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (C...[ Price : $8.95]
FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila ...