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The ALS Association calls on FDA to act with more urgency on approval of Amylyx AMX0035 that reported a successful Phase 2 trial.[ Price : $8.95]
FDA posts several new postmarket activity modules on its CDRH Learn Web page.[ Price : $8.95]
CBER publishes its calendar year 2021 guidance agenda with 16 items in four categories.[ Price : $8.95]
FDA grants accelerated approval six weeks before the goal date for Immunomedics Trodelvy in some urothelial cancer patients.[ Price : $8.95]
FDA publishes a Covid-19 guidance on remote interactive evaluations of drug manufacturing and storage, bioresearch monitoring, and...[ Price : $8.95]
FDA acting FDA commissioner Janet Woodcock says the agencys pandemic recovery phase planning will prioritize facility surveillance...[ Price : $8.95]
FDA clears an expanded indication for the Avitus Bone Harvester.[ Price : $8.95]
FDA and CorMedix agree to a study protocol required in the agencys DefenCath complete response letter.