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FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium...[ Price : $8.95]
U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.[ Price : $8.95]
FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call ...[ Price : $8.95]
Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation...[ Price : $8.95]
Former FDA regulatory counsel Jessica Ritsick joins Alston & Birds FDA practice in Washington, DC., after an 11-year career at the...[ Price : $8.95]
FDA accepts for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinet...[ Price : $8.95]
A MedShadow online post says President Trumps executive order to increase unannounced foreign drug inspections could help improve ...[ Price : $8.95]
Citing an inadequate clinical trial, FDA refuses to file an Axsome NDA for its fibromyalgia drug AXS-14 (esreboxetine).