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FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national securi...[ Price : $8.95]
Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for ...[ Price : $8.95]
The Consumer Healthcare Product Association tells CDRH patient self-diagnosis need not be a requirement for the at-home use of ove...[ Price : $8.95]
FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Hunt...[ Price : $8.95]
FDA places a partial clinical hold on Gilead Sciences studies evaluating magrolimab to treat acute myeloid leukemia.[ Price : $8.95]
FDA accepts for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-depend...[ Price : $8.95]
Federal Register notice: FDA decides not to add ephedrine sulfate and hydroxychloroquine sulfate to its list of bulk drug substanc...[ Price : $8.95]
Federal Register notice: FDA corrects an 8/14 notice that announced a modification to the organizational structure of CDRHs Office...