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).
Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for us...
A JAMA viewpoint article raises alarms about FDAs full approval last month of Novavaxs Covid-19 vaccine and the agencys unusual delay and politically ...