FDA orders some Propecia labeling changes sought in a 2017 petition and denies most of the other changes sought.
The U.S. House of Representatives votes 392 to 28 to pass the Food and Drug Amendments of 2022), which would reauthorize FDA user fee programs for pre...
FDA sets a Class 1 designation on a recall of GE Healthcares ventilator batteries used in certain Carescape R860 Ventilators.
Federal Register notices: FDA renews the charters for four advisory committees for an additional two years.
Federal Register notice: FDA sends to OMB an information collection extension entitled New Animal Drug Applications and Veterinary Master Files.
Moderna says its bivalent Covid vaccine booster specifically targeting the Omicron variant achieved superior antibody response against Omicron and cou...
CDER issues a MAPP outlining the roles and responsibilities of the Office of Generic Drugs and Office of Surveillance and Epidemiology in assessing th...
Lawmakers introduce a bill to ensure access to over-the-counter oral birth control drugs.