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Federal Register notice: FDA provides an opportunity to submit written comments on recommendations by the World Health Organizatio...[ Price : $8.95]
Eisai CEO Ivan Cheung says he expects full FDA approval for the early Alzheimers drug Leqembi by this summer if the agency gives t...[ Price : $8.95]
FDA approves Chiesis Lamzede to treat some manifestations of alpha-mannosidosis in adults and children.[ Price : $8.95]
Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agenc...[ Price : $8.95]
FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and AN...[ Price : $8.95]
FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health informa...[ Price : $8.95]
FDA clears a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe.[ Price : $8.95]
FDA approves Apellis Pharmaceuticals Syfovre to treat geographic atrophy secondary to age-related macular degeneration.