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.
As it heads into a Phase 1 study, FDA grants Pheast Therapeutics a fast-track designation for PHST001 and its use in treating patients with advanced p...
HHS secretary removes all 17 members of the CDCs Advisory Committee for Immunization Practices (ACIP), and plans to appoint new members in the coming ...
FDA approves a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus lower respiratory tract disease in neonates and i...
Citing an inadequate clinical trial, FDA refuses to file an Axsome NDA for its fibromyalgia drug AXS-14 (esreboxetine).
