An Eagle Pharmaceuticals 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke has been accepted for priority review.
Allergan says it will file an NDA in the second half of this year after announcing data from two Phase 3 trials of sarecycline for treating moderate t...
FDA denies an Osmotica Pharmaceutical petition asking the agency to require that any ANDA seeking approval of venlafaxine HCl extended-release tablets...
As Congress and president Trump pledge to address skyrocketing drug costs, a new report by consumer advocacy group Public Citizen calls into question ...
A new report by Pew Charitable Trusts says that currently available data on antibiotic use in the U.S. are insufficient.
Senate Health, Education, Labor & Pension committee chair Lamar Alexander (R-TN) says a confirmation hearing will be scheduled soon after the committe...
FDA approves an iCAD PMA for its PowerLook Tomo Detection device, a concurrent-read computer aided detection product for digital breast 3D tomosynthes...
FDA Review posts Federal Register notices for the week ending 3/24/2017.