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An FDA joint advisory committee votes 27 to 0 to not recommend approval of Nektar Therapeutics oxycodegol for back pain.[ Price : $8.95]
FDA updates the list of biological products that will be deemed to be BLAs on 3/23 to include chemically synthesized polypeptides.[ Price : $8.95]
A McDermott Will & Emery review of FDA activities in 2019 finds a slight decrease in overall enforcement activity as the agency co...[ Price : $8.95]
FDA approves a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), indicated for the introduction of local ane...[ Price : $8.95]
FDA asks members of the Anesthetic and Analgesia Drug Products Advisory Committee to evaluate whether Durect has provided sufficie...[ Price : $8.95]
FDA staffers discuss the future role of machine learning in drug development and regulation.[ Price : $8.95]
CDRH associate director Erin Keith says the Center will be issuing more Warning Letters now that staff are getting used to an inte...[ Price : $8.95]
FDA clears a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea.