FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium.
U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.
FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call a new FDA.
Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder and its use ...
Former FDA regulatory counsel Jessica Ritsick joins Alston & Birds FDA practice in Washington, DC., after an 11-year career at the agency across numer...
FDA accepts for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinetrione oral antibioti...
A MedShadow online post says President Trumps executive order to increase unannounced foreign drug inspections could help improve domestic drug manufa...
Jaguar Health plans to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea in breast cancer patients after gaining FDA support.
