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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).[ Price : $8.95]
Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PC...[ Price : $8.95]
A JAMA viewpoint article raises alarms about FDAs full approval last month of Novavaxs Covid-19 vaccine and the agencys unusual de...[ Price : $8.95]
Jaguar Health plans to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea in breast cancer patients after g...[ Price : $8.95]
As it heads into a Phase 1 study, FDA grants Pheast Therapeutics a fast-track designation for PHST001 and its use in treating pati...