FDA accepts for filing a Shire BLA for lanadelumab to treat hereditary angioedema and will give it a priority review.
FDA says a 10-year follow-up study confirms an increased risk of heart problems in heart disease patients prescribed Biaxin.
CNBC reports that FDA commissioner Scott Gottlieb wants changes in right-to-try legislation being backed by President Trump.
PricewaterhouseCoopers says FDA approved 14% more generic drugs in 2017 than in 2016.
The Federal Trade Commission reaches a settlement with Telomerase Activation Sciences barring it from making unsubstantiated claims for either of its ...
Federal Register notice: FDA announcesa 3/21-22 joint meeting of its Blood Products Advisory Committee and the Microbiology Devices Panel of the Medic...
Federal Register notice: FDA seeks comments on an information collection exetension for Medical Device Labeling Regulations 21 CFR parts 800, 801, an...
FDA accepts for review a Medicines360 supplemental NDA that seeks to extend the duration of use for preventing pregnancy from up to four years to up t...